WE are having NxStage go back over the past year and see if we used any of the contaminated saks.This sort of thing is why I keep my treatment flow sheets in an SQL database 8) - It makes it real easy to look this sort of thing up.
WE are having NxStage go back over the past year and see if we used any of the contaminated saks.This sort of thing is why I keep my treatment flow sheets in an SQL database 8) - It makes it real easy to look this sort of thing up.
@ Speedy1wrc
I have been concerned about the lactate in the dialysis for some time.
I had my blood levels checked before and after a session and the level was 10 mg/dL (reference range 4-16 mg/dL) at the start of the session and 56 mg/dL at the end of the session. This is a 460 percent increase. No one at Davita seemed concerned, but I was shocked.
I requested changing to bicarbonate dialysate, but Nxstage turned me down (so I was told by Davita).
@ Speedy1wrcNxStage did not turn you down. The NxStage system is lactate based; the BabyK and 2008 series Fresenius machines are bicarb based. NxStage could inform you "we don't have a bicarb based system", however, only your clinic or Dr. could actually "turn you down".
I requested changing to bicarbonate dialysate, but Nxstage turned me down (so I was told by Davita).
I spoke to legal counsel yesterday, and he cautioned me to revealing symptoms of alleged aluminum poisoning on an open forum.He wants to preserve your ability to file contingency fee litigation, and wants the bags preserved as evidence. "Don't talk about the case except to your legal team" is the first thing any civil or criminal lawyer will tell the client.
He also recommended I hold on to any unused SAKs affected by the recall, and not turn them back to the dialysis clinic.
These are the lot numbers of the SACs in question:
Jan 2014 40179127, 40179107,40179106,40179105, 40179093,40179034
Dec 2013 31279120, 31279118
May 2013 3057921,3057920,3057915,3057914,3057906,3057905
April 2013 3047924,3047923
Note I am not sure if these are the complete list or just the ones relevant to NKC
Bill:
The bicarb-based PAKs are a two stage design which requires mixing before use. Shelf life is not the issue. Nxstage profits are.
I am quite disappointed in the NxStage letter implying that the levels of aluminum in patients will only be about 10 with the normal level up to 9. Not true, mine two months ago was over 20. Sorry, but not happy with this whole episode. Where is their quality control that patients have to tell NxStage that there is a problem Houston. That is NOT the way it is supposed to work.11.1 To prevent aluminum toxicity, the regular administration of aluminum should be avoided and the dialysate concentration of aluminum should be maintained at <10 µg/L. (EVIDENCE)
Hemodoc, you express my sentiments quite well. Among the many questions I have are (1) "likelihood of any serious adverse health consequences is remote," claims Nxstage. What adverse effects (even seeming minor ones as Nxstage might define it) have been reported? What physical and mental symptoms have been reported that should be monitored and addressed?
Question (2) is why is there any aluminum in the SAKS AT ALL? Sodium lactate in its chemical form contains no aluminum ions. How the hell did the aluminum get into the lactate to begin with?
As I have written before, an FDA investigation is called for to get to the truth that Nxstage has yet to reveal.
I have reviewed the Nxstage product recall letter which is addressed to CUSTOMERS of Nxstage. I am a patient associated with a Davita clinic. Davita is Nxstage's customer.
I see no reason why I am obligated to fill out and SIGN the "Recall Reply Form" they have attached to their recall notification.
I will discuss the ramifications of this form with my attorney on Monday, however, I foresee that he will reach the same conclusion as I have noted above.
How is 'Serum Aluminum' listed on my lab results listing?In most clinics it is only done once a year or every few months. It has to be specially drawn and ordered. Ask your nurse to draw it. It should just say aluminum.
I don't recognize anything with 'Aluminum' in it?
I' ve been using a bunch of the recalled SAKs.
We’ll know units are applying this lesson if people who are having trouble with thirst (aka sodium) first have their dialysate checked before being given the sodium lecture. Again.
From what i could read these FDA filings are nothing but mislabelings and user screw ups, and are OLD. Many are from 2005 to 2008 when the system was fairly new. I dont see any smoking guns.That's more or less what I saw. However with so many "operator error" diagnosis it leads me to question so many "not our fault" findings. Is that truly a case of so many bad operators or a profound denial that anything is wrong? A lot of little errors is still indicative of a culture of mistakes. Where is the quality control? And arguably if that number of errors are caught, how many are missed? I have had issue with aluminum for some time as well. The denial that there could be any problem with the SAK's came directly from NxStage a year ago. Without anything to back it up, they flat out denied there could be anything wrong with the SAK's. A year ago they could have taken action so see if there was a problem. We went to them with our test results in hand to say we've eliminated everything else, we think there is a problem, but with the culture of denial they just dismissed it. Am I off base thinking that every lot should be tested? I test every batch for chloramines. Monthly I test the SAK for contamination. At least quarterly I check a PAK sample. I take every precaution to ensure my safety and well being, it doesn't seem like they do.
From the research I did about high aluminum levels, the aluminum can be stored in organs like the heart and brain. Is there any way to know if we have excess aluminum in our organs? And can anything be done to remove it? I am definitely not liking the studies linking high aluminum levels to Alzheimer's. Most of the websites claiming to remove aluminum from the body seem like scams to me. I also read something about a chelation process, but was unclear if that would remove the stored aluminum. Any help would be appreciated! Thanks.I've only heard about chelation with regards "treating" autism. From what I've read about it (years ago) it may remove heavy metals from your system, but it's dangerous. I think it goes in the scam column.
From the research I did about high aluminum levels, the aluminum can be stored in organs like the heart and brain. Is there any way to know if we have excess aluminum in our organs? And can anything be done to remove it? I am definitely not liking the studies linking high aluminum levels to Alzheimer's. Most of the websites claiming to remove aluminum from the body seem like scams to me. I also read something about a chelation process, but was unclear if that would remove the stored aluminum. Any help would be appreciated! Thanks.I've only heard about chelation with regards "treating" autism. From what I've read about it (years ago) it may remove heavy metals from your system, but it's dangerous. I think it goes in the scam column.
Thanks for the info! My highest level was 30, and then came down to 16/17 and stayed there until my transplant in March, so it doesn't appear that chelation is something I need. Curious if there is a way to measure stored aluminum in the body? The fact that I am worrying about this makes me very angry at NxStage!
I have been trying to research such effects of long term elevated aluminum levels and indeed there isn't very much out there. While it appears clear that there is a distinct correlation, how much and for how long is still up for debate. While there is little argument we all have been harmed, a court would expect some sort of quantitative amount of damage which I don't know if anyone of us could prove.
Hemodoc was right about FMC elevating this to NxStage after exhausted testing since last Summer. Kudos to a few medical directors and patients who made this happen.. Of course it took too long and along with others I'm not happy with NxStage's response . Got a feeling that will change. I hope so because I love their system.
Hemodoc was right about FMC elevating this to NxStage after exhausted testing since last Summer. Kudos to a few medical directors and patients who made this happen.. Of course it took too long and along with others I'm not happy with NxStage's response . Got a feeling that will change. I hope so because I love their system.
Most clinics have only a handful of patients on NxStage making it difficult to consider NxStage SAKs as the source. There are only two of us in my clinic with NxStage, but none of us put together that connection with NxStage. In retrospect, we should have but I had other confounding issues at the time with some of my medications that may have been simply a red herring leading us away from the correct diagnosis.
I have been considering changing over to the Baby K for a few months because of the volume issue with NxStage, not enough, but I have held on due to my appreciation of their ultra-pure dialysate. I am beginning to seriously question whether I SHOULD continue with NxStage waiting for the next shoe to drop so to speak. This entire episode leaves me with little confidence in them to pre-emptively self monitor for complications. Is NxStage a disaster waiting to happen?
This aluminum case reminds me of nothing so much as the granuflo case, where a change in inputs had unintended consequences.
With the entire issue of oversized PAK's which I just had another one two days ago that didn't fitWas it an older lot that didn't get caught or a current lot number?
With the entire issue of oversized PAK's which I just had another one two days ago that didn't fitWas it an older lot that didn't get caught or a current lot number?
This especially as Baxter and FMC are on the verge of entering the home hemo market.The sorbent based systems look very interesting, and could be a game changer.
My wife was undoubtedly contaminated with Sak 302 lot 3047913 and/or 3037904 which were NOT on the recall sheet. Her AL level was mid 20's in the 1st week of last July. I used these lot numbers exclusively for 6 weeks prior to the high AL test. The recall sheet showed the very first contaminated Sak we used was treatment on July 29th. Just got off the phone with Nxstage who to their credit called me back 4 days after I asked them to explain. They said if it's not on the list the product was good. There was no answer to my question "Well how do you think she was contaminated?". They were kinda surprised I had the lot numbers then I reminded them we record every lot number each treatment day.....then a silence on the other end. Still think they will eventually fess up with more recalls. Stay tuned.
"The smoking gun has been found." Notice the DATE.
Rockwell signs dialysate supply contract with NxStage
March 08, 2013
KEYWORDS nxstage / Rockwell
Email / Print / Reprints /Notice the location . I knew they were getting the dialysate from down in Texas and Mexico. Here is the culprit.
Rockwell Medical
4051 Freeport Pkwy # 100,
Grapevine, TX 76051
(972) 874-2130
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Rockwell Medical has signed a two-year contract with NxStage Medical Inc. to manufacture dialysate concentrate for the portable home dialysis machine the NxStage System One.
"We are pleased to enter into a supply relationship with NxStage, a leader in home hemodialysis," said Rob Chioini, Chairman, CEO and President of Rockwell.
I am willing to bet they had a specification for aluminum and were relying on their vendor to ensure it was meeting specification.
Speedy, the dates of Rockwell's involvement need to line up with your onset of symptoms in late February or March 2013. If there product was not involved until May, then that doesn't explain your earlier involvement.Agreed, and by calling I wanted to see what they had to say. They could easily say they did what they were expected to do. But we all have a lot of questions and right now few answers. It's time to get answers.
We need more information before we can draw clarity on this.
I agree wholeheartedly! Everything they ship out the door should be tested as thoroughly as possible and then some.QuoteI am willing to bet they had a specification for aluminum and were relying on their vendor to ensure it was meeting specification.
I believe that every batch of beer is tested for alcohol content before shipment, and I expect Jack Daniels does some quality control before it bottles its stuff. It would seem to make sense to test the lots of solution for conformance to spec before packagiing them.
Speedy, the dates of Rockwell's involvement need to line up with your onset of symptoms in late February or March 2013. If there product was not involved until May, then that doesn't explain your earlier involvement.Agreed, and by calling I wanted to see what they had to say. They could easily say they did what they were expected to do. But we all have a lot of questions and right now few answers. It's time to get answers.
We need more information before we can draw clarity on this.
Thi is the date of announcement only. They could have started much earlier!!!
March 8, 2013
Rockwell Medical Signs Supply Contract With NxStage(R) Medical
WIXOM, MI -- (Marketwire) -- 03/08/13 -- Rockwell Medical (NASDAQ: RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis, announced that it has signed a contract with NxStage® Medical, Inc. to manufacture dialysate concentrate for the NxStage System One™, the first and only truly portable hemodialysis system cleared for home use by the U.S. Food & Drug Administration. The contract term is for two years.
My nurse just called me at work 1/2 hour ago to tell me to text her my SAKs lot numbers when I get home. I know for sure that I'm using 401 and have to drain my Pure Flow tonight. I'm glad this is my off night. No wonder I felt confused most of the time, a little agitated, and some muscle rigidity. DaVita is slacking up.... Praise God that they discover this problem. :oMy husband has only been doing home hemo for 6 months using Pureflow SAKS. We don't have any of the bad SAKS but he has been feeling confused and agitated lately. He has high blood pressure so the smallest amount of stress makes it worse. Our Fresenius center called right away about the recall, so that was good but still, makes us feel a little nervous about the whole thing. His BP hasn't been too bad the past couple nites tho...we discovered the MC (Music Choice) channel on our TV and love listening to oldies but goldies, 70's rock and swing, livens up treatment sessions for us and gets our minds off all this stress. I've read a lot of your posts and think you are a strong person and have a good attitude. Hope some of that rubs off on me, too! Thanks for being an inspiration!! :beer1;
I just dumped a bunch of leaky bags today and the labels said they were made in Mexico. I am not certain the bags are any better, possibly as bad or worse. With the PAK issue I had been on bags for almost a month concluding maybe 2 weeks ago. My aluminum which was drawn on the 15th had risen to 20. I did use a known(after the fact) SAK just prior to the draw so that possibly could have been a major contributor.What is your calcium level?? Some of those symptome may be from hypercalcemia which can occur from high aluminum. Also check your magnesium as that can also do it.
On the Rockwell website they claim their manufacturing facilities are in the United States. I plan on asking them when and if they return my call.
I noted some symptoms mentioned above. I hadn't connected them to the aluminum till now but it is making more and more sense.
As far back as last year I have had the metallic taste in my mouth. I have had several surgeries for sleep apnea but still have had odd symptoms which my ENT Dr can't explain. I have difficulty swallowing and we have attributed it to a lack of saliva. My mouth dries out and my nose is always very dry. I also spend a lot of time itching my calves. So much so I have sores on my lower legs. Being Winter we assumed it was the dry air, now that it is Spring, I still have it and going back on the SAK's a couple weeks ago, it has gotten much worse. Muscle strength. For the last year I have struggled with any sort of physical activity. I am constantly off balance and I tire easily. A little over a month ago I fell and ended up with a concussion. Two weeks after that I fell face first and banged myself up pretty good. My appetite is horrid. My dietician has been baffled. I sometimes go all day without eating because I can't. When I do eat, after a few bites I feel awful. I can't remember anything. The other day my girlfriend and I went to a garage sale nearby. We took a different route there and back. My girlfriend asked why, and I told her I saw a sign for a sale on a road next to ours. We have lived there over 5 years and I am from this area. I couldn't remember the name of the road one block down from our house. I am constantly forgetting appointments. Completely forgetting, not just having them slip my mind. People are always telling me things I should know and it's as I I never heard it. The one that caught my eye above was muscle twitches. This has been something that started maybe 6 mos. ago. Insomnia notwithstanding the twitches drive me nuts. I can't even attempt to sleep without Gabapentin to make the twitches stop. The side effects are not fun though. There is so much pain on both my index fingers that there aremdays I simply can't use them. I am certainly not old enough for arthritis and the onset has been very rapid. Most days I can't get down on the floor to do any sort of work knowing that I can't get back up. My knees are in horrific pain. It has come about within the last 6 to 9 mos. My teeth are also starting to deteriorate rapidly.. The edges are getting all pitted and wearing away. Again this has been a recent occurance with no other known cause.
I had initially thought I had only a few symptoms but after hearing from everyone I think I have a lot more ailments related to the aluminum than I had originally believed. My girlfriend and I have been discussing the symptoms and she hasn't said anything but tonight admitted she had noticed a change in me. She has noticed me grabbing onto counters in the kitchen to steady myself or catch myself to keep from falling. Being a nerdy engineer she has noticed I haven't been as sharp as usual. I always have the answer, but more recently I stumble over my words and I struggle trying to help my daughter with her math homework. Math is my thing and I am frustrated when I get lost on simple problems.
This is much worse than I suspected. We are finding a lot of dirt and tying symptoms to the aluminum. This is getting bad.
I am not currently on dialysis, but I have been watching this thread with great interest. I have always looked at NxStage as the be all end all for dialysis treatment. I was on in-center HD for 7 months back in 2011 before receiving a live donor transplant. I would have looked into using NxStage had my tx not happened.
What I want to know is this - why is the only concern being expressed on this site? I belong to many kidney groups on Facebook, and can't even really find anything in the NxstageUsers group. Is this weird? Why is no one else concerned? I for one am really bothered by all of this, because if I ever need to go back on dialysis, I don't know what I will do. I really don't want to do PD, because I don't like the amount of time it takes. If I do HHD, NxStage is the only thing that can fit in my home.
Any thoughts as to why other dialysis communities don't seem to be as concerned about all of this?
KarenInWA
What I want to know is this - why is the only concern being expressed on this site? I belong to many kidney groups on Facebook, and can't even really find anything in the NxstageUsers group. Is this weird? Why is no one else concerned? I for one am really bothered by all of this, because if I ever need to go back on dialysis, I don't know what I will do. I really don't want to do PD, because I don't like the amount of time it takes. If I do HHD, NxStage is the only thing that can fit in my home.
Any thoughts as to why other dialysis communities don't seem to be as concerned about all of this?
KarenInWA
I want to remind everyone this is just the tip of the iceberg. Or in other words dont miss the forest for the trees.
This aluminum problem appears to be part of a much wider problem . In a way it is a syymptom rather than the only issue.
We have here an industry that we cant trust and are at the mercy of. Do any on you trust any of the dialysis products you use now? I dont.
We have Nxstage and Rockwell and perhaps others that we have to question now.
Rockwell may have produced the tainted dialysate for nxstage. It certainly appears from their announcements they did. Rockewell also produces much of the in center dialysate concentrates (acid and bicarbonate) for Fresenius and DAvita. They had at least one substandard manaufacturing plant in SC that had multiple serious violations that could have tainted their product. Every dialysis patient in the country could at some point be effected.
Now we have Rockwell trying to get their new drug for anemia aproved to replace or reduce EPO that will go dirctly into the dialysate in center. They have been accused of falsifying their test results and lying to the SEC and FDA.
This is a deep tangled web . And I am sure we only have a small part of the story.
So dont just focus on aluminum. That may turn out to be the least important part of the story. It may be a LOT worse than that.
Please post the results when available. Tks.
I am not sure what you expect NxStage to do if someone has problems. Of course it is up to the units to sort out any problems that have occurred. What are NxStage supposed to do? I am sure that there is Likely to be a class action lawsuit and NxStage's responsibility will be to pay out monetary compensation. I am pretty sure that their legal team have already primed them what yo say to patients. Not sure how easy it will be to prove that harm has been done unless as Peter says, people have invasive procedures such as bone biopsies.
3) Compensation for anyone harmed by their product right now.
3) Compensation for anyone harmed by their product right now.
"Compensation" is tricky, given the difficulty of proving an elevated AL level is responsible for problems. Mine went from 5 to 13 while on the bad SAKs. Should I be compensated due to the worry and anxiety even though, at present, I have no symptoms from the NxStage product other than continued life? I'm sure some contingency fee lawyer will have ads on late night TV offering to sort this out for us.
Individual lawsuits are notoriously difficult to prove with 90% going in favor of the practictioner. Class action lawsuits are a different story.Yup - It's an entirely different ballgame that auto accidents where the insurance companies will settle even in the fact of a police report showing the defendant driver was not at fault.
Anyone get recent aluminum values yet? I had mine checked two weeks ago then day after the recall. I just had it checked again Wednesday. I was expecting the results today, but they weren't back yet. I hope to have them Monday.
My wifes aluminum is at 44. She is small so it accumulated a lot. I am not happy about it. We are deciding what to do about it now. Our nephrologists are not happy either. WE certainly will moniter it closely now.
My wifes aluminum is at 44. She is small so it accumulated a lot. I am not happy about it. We are deciding what to do about it now. Our nephrologists are not happy either. WE certainly will moniter it closely now.
I am so sorry your wife's levels are still so high. I am still unclear about the accumulated aluminum. Will it be filtered out by dialysing with uncontaminated SAK's? How much aluminum stays in the tissue? Sorry if this is a stupid question, but I am not finding any clear answers in my research. Maybe I have missed something.
Can the aluminum be removed via sweeting?
So many unanswered questions for NxStage. Glad the article was written and thanks to those who participared. Still can't believe no lawsuites.
Just FYI, after being in the 20's for a year our aluminum is now 13 after using the "uncontaminated" sacs. Still surprised they allow 10 micrograms in their processing as an upper limit. Wonder if that has been changed. I certainly hope so.
Thank you, Hemodoc for including the link to your article. This whole thing (SAK recall) has been upsetting and their quality control has lost some credibility. We will continue using NxStage products but this is very angering, very disappointing and downright scary.
I spoke with an official at NxStage as well.I'm very surprised that they would even talk to you. Being a corporation I'm sure that they have had some guidance from their legal department on what to say - nothing - and who to say it to - no one. Even if an executive wanted to do say something publically I'm quite sure that their legal team would block it as much as possible. They are in a protected situation where the centers are their clients, and they can defer all patient communication to the centers. The legal team would re-enforce that relationship as much as possible because it prevents employees from talking to patients.
"Yeah we knew the SAKs were 'beyond spec' but the issue didn't rise to the level serious enough to dump 140,000 already manufactured units...and also 'we had no reports of problems from the field' [FALSE as posters on IHD have stated]...' "If the NxStage contract negotiation team was on the ball, the supplier to NxStage, and not NxStage, would bear the financial risk of any product delivered to NxStage out of spec.
"Yeah we knew the SAKs were 'beyond spec' but the issue didn't rise to the level serious enough to dump 140,000 already manufactured units...and also 'we had no reports of problems from the field' [FALSE as posters on IHD have stated]...' "If the NxStage contract negotiation team was on the ball, the supplier to NxStage, and not NxStage, would bear the financial risk of any product delivered to NxStage out of spec.
The only problem with that is that NxStage knew it was "out of spec" and they decided to still use it. That is their problem right now."Yeah we knew the SAKs were 'beyond spec' but the issue didn't rise to the level serious enough to dump 140,000 already manufactured units...and also 'we had no reports of problems from the field' [FALSE as posters on IHD have stated]...' "If the NxStage contract negotiation team was on the ball, the supplier to NxStage, and not NxStage, would bear the financial risk of any product delivered to NxStage out of spec.
The only problem with that is that NxStage knew it was "out of spec" and they decided to still use it. That is their problem right now."Yeah we knew the SAKs were 'beyond spec' but the issue didn't rise to the level serious enough to dump 140,000 already manufactured units...and also 'we had no reports of problems from the field' [FALSE as posters on IHD have stated]...' "If the NxStage contract negotiation team was on the ball, the supplier to NxStage, and not NxStage, would bear the financial risk of any product delivered to NxStage out of spec.
Also Nxstage knew most centers only test for aluminum once or twice a year (or not at all). Our Al was tested at 25 the first week of June 2013 using saks not even on the recall list. If I'm Nxstage all I'd have to do is check with their own Spectra Labs and ask "Hey, any high aluminum numbers out there?". I'll bet they did and the coverup was on.
The NxStage Sak recall has (finally) appeared on the weekly "FDA Enforcement Report"
Here is a link to the Report:
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&source=govdelivery&utm_medium=email&utm_source=govdelivery&w=07022014 (http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&source=govdelivery&utm_medium=email&utm_source=govdelivery&w=07022014)
The recall designated by the FDA as a "Class II" event. Here is the FDA's definition of that: (Red highlight added)
***begin FDA clip***
Classification - Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard.***end FDA clip****
- Class I: Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.
- Class II: Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.
- Class III: Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. Examples include: a minor container defect and lack of English labeling in a retail food.
The report doesn't provide any "how it happened", mostly a repeat of what we got from NxStage.
Interestingly, it describes the scope of the recalled product as:
"Worldwide Distribution - USA (nationwide) and Internationally to France, Netherlands, Spain, Sweden, and the UK."
Perhaps those more knowledgeable about how the FDA does things can chime in as to whether more detailed info from FDA is likely coming??
--Dan
Anyone want to know the results of our little bag vs. SAK test? Probably not...
So I started about 7 weeks ago on bags. The goal was simple, to see if my aluminum went down while other controls stayed on SAK's.
Let me say, I am staying off then Pureflow for good now. I think you know where this is going. After 3 weeks my aluminum went from 20 down to 16. After 4 more weeks it is now down to 11. The controls still on SAK's still have high aluminum levels.
Are the SAK'sstill contaminated? We don't know. Or is the bigger question, are they within spec which is just too high? In either case it is clear, being on SAK's even now will make your aluminum level high.
For me the solution is to pitch the Pureflow to the curb. I spoke with Peter at length on the phone and he is done with the Pureflow as well. In speaking with several others, they too are switching.
Hopefully NxStage finally extracts their collective heads from the sand and decide to do something. I would much prefer to use the Pureflow, but at the expense of my health.
What say you?
Also my wife has PKD and PKL. I'm not a doc but the common denominator of high Al with our sac users was liver disease.
I'm sure we'll hear that it takes time to rid the blood of aluminum because it equilabrates from the tissue back into the blood where it can be removed. But if we're getting dosed from the sacs the levels will never go down as we found out last yr. (and now, as well). Also as I've mentioned, we went in-center for a month in Feb. and never got below 10 which lends some credence to the tissue theory. At any rate tissue theory or not if the sacs have 10 mcg we're all in trouble.My level dropped from 20 to 11 in roughly 7 weeks on bags. It has been in the 20 range for a year and a half on SAK's.
I dont buy the liver disease having anything to do with aluminum levels. My wife has the highest aluminum posted here at 40, and has a perfect liver. Her liver is amazing as it can suck up any drug and elininate it quickly. We always have to dose her way up on meds due to her highly effective liver function.I'm sure we'll hear that it takes time to rid the blood of aluminum because it equilabrates from the tissue back into the blood where it can be removed. But if we're getting dosed from the sacs the levels will never go down as we found out last yr. (and now, as well). Also as I've mentioned, we went in-center for a month in Feb. and never got below 10 which lends some credence to the tissue theory. At any rate tissue theory or not if the sacs have 10 mcg we're all in trouble.My level dropped from 20 to 11 in roughly 7 weeks on bags. It has been in the 20 range for a year and a half on SAK's.
I have used 40 liters since my second month on NxStage at home. Yes, more dialysate, more aluminum.That's what I'm afraid of. So whether or not you are a large person or in need of/wanting to run at a higher volume, it's going to be "punishing". THAT really concerns me and it definitely makes you question doing a higher volume to get uh, "better" dialysis...
I have used 40 liters since my second month on NxStage at home. Yes, more dialysate, more aluminum.That's what I'm afraid of. So whether or not you are a large person or in need of/wanting to run at a higher volume, it's going to be "punishing". THAT really concerns me and it definitely makes you question doing a higher volume to get uh, "better" dialysis...
I agree!I have used 40 liters since my second month on NxStage at home. Yes, more dialysate, more aluminum.That's what I'm afraid of. So whether or not you are a large person or in need of/wanting to run at a higher volume, it's going to be "punishing". THAT really concerns me and it definitely makes you question doing a higher volume to get uh, "better" dialysis...
I would hope you and others don't conflate higher dose dialysis as something bad. No, NxStage aluminum contamination is very bad. High dose dialysis is not. Let's keep the focus where it should be, getting NxStage to clean up their act. In the mean time, I am done with the PureFlow. High dose dialysis is our friend. NxStage right now is not.
Curious to know what those of you who are no longer going to use Pureflow/SAKS anymore are going to do. Hang bags? Go back to doing in-center? Use a different home-hemo machine or modality? What about high volume dialysis? We use the NxStage Cycler and still fairly new to this. My concern is that if you want/need to do more than 25 liters of dialysate (25 liters involves hanging 4 bags on the IV pole with a 5th on the warmer), you'd have to (if I'm correct) repeatedly clamp off bags as they empty, remove them from the IV pole and then connect new bags during treatment to do a higher volume. Or is that something we are just going to have to do if we should decide to no longer use Pureflow SAKS? Yikes!The other option is getting a seperate IV pole to hang extra bags .
The other option is getting a seperate IV pole to hang extra bagsBeen there, done that, works great.
@ Hemodoc
I have read a Nxstage document, that I can not at the moment put may hands on, that use of the Pure Flow was an optional accessory to use of the Nxstage therapy system. How did FMC force you to use the PureFlow? I appreciate that the issue is now moot.
There's actually a warmer line for 8 hanging bags. Nxstage number FWS 308......24 to a case. Also they have a stronger pole that doesn't collapse or break down. We're taking aluminum today. If not going down we'll likely go to bags (6-30L).This is good to know, thanks! I might inquire about getting those to keep in our inventory and especially if we end up having to forego using the Pureflow SAKS because of aluminum issues. I don't know if we have the most current model of the IV pole, the one we have came in 2 pieces, sits on a sort of small square hard plastic stand while also screwed/bolted to the back of the cycler. We have the Express Warmer that sits on-top.
@ Hemodoc
The only satisfaction I am getting from this situation is the costs of the bags and shipping will eat into Nxstage's profits.
@ speedy
I will likewise never go back to in-center. We are all between a rock and a hard place. We need the choice of other in-home dialysis modalities desperately.
There's actually a warmer line for 8 hanging bags. Nxstage number FWS 308......24 to a case. Also they have a stronger pole that doesn't collapse or break down. We're taking aluminum today. If not going down we'll likely go to bags (6-30L).This is good to know, thanks! I might inquire about getting those to keep in our inventory and especially if we end up having to forego using the Pureflow SAKS because of aluminum issues. I don't know if we have the most current model of the IV pole, the one we have came in 2 pieces, sits on a sort of small square hard plastic stand while also screwed/bolted to the back of the cycler. We have the Express Warmer that sits on-top.
My husband sees his Neph on Thursday and hopefully agrees to testing his aluminum level. If not at clinic, then when I do next month's labs at home. Once we know what his aluminum level is, I'll post it. We never got any of the "bad" SAKS but since his baseline was never taken, we definitely want to know what his level is at.
My wifes aluminum only dropped from 40 to 39. We are still using pureflow so I am not happy. I am considering asking about using hanging bags .
This is really frustrating.
Correction to above post: When the cycler indicated "5L" remaining hit stop and connect the bag.
I've been out of the loop for awhile.Is there a typo? You are reporting the bags tested higher than the saks.
Maggie's AL when up while using Saks this last month.
We AAMI tested 2 Sak lots and one Hanging bag lot
Both the Saks tested .005
The Hanging bags tested >.005
We are switching to hanging bags.
I've been out of the loop for awhile.Is there a typo? You are reporting the bags tested higher than the saks.
Maggie's AL when up while using Saks this last month.
We AAMI tested 2 Sak lots and one Hanging bag lot
Both the Saks tested .005
The Hanging bags tested >.005
We are switching to hanging bags.
No typo 2 SAK lots showed .005Where I come from, ">" means greater than and "<" means less than.
The hanging bags showed less than (>).005
No matter where anyone is from, the universal symbol for LESS THAN is "<" and GREATER THAN ">" This might help to remember:You mean it's not like driving on the right side of the road vs. driving on the left, or a right hand vs. left hand stereoisomer :rofl;
Question: Due to the aluminum toxicity issue with Pureflow SAK's, we told my husband's Neph that we want his aluminum level tested and she said she would order it. We do his monthly labs at home and take it to the clinic (Fresenius). The clinic then sends it to Spectra. My question is, does anyone know if his aluminum level can be tested using one of the usual monthly test tube vials or does/should it involve a whole separate vial of blood to be drawn? We normally draw "pre" dialysis: Tiger tube and Lavender and the Gold "post" dialysis. We plan on calling the center tomorrow during business hours to find out but thought I'd ask if anyone on here knows. Thanks.
You will need a separate dark blue top tube and best drawn pre-dialysis. Also, you should not take vitamins or mineral supplements a couple of days before the blood draw.
Spectra, like most labs used by dialysis centers, send the blood elsewhere to be tested. - http://www.spectra-labs.com/laboratories-test-menu#search
There's actually a warmer line for 8 hanging bags. Nxstage number FWS 308......24 to a case. Also they have a stronger pole that doesn't collapse or break down. We're taking aluminum today. If not going down we'll likely go to bags (6-30L).
Also, if you want to use the Nxstage dose calculator just put in a phone number when it asks for your medical #. It worked for me and I've been using it to actually lower our speeds.
Also, if you want to use the Nxstage dose calculator just put in a phone number when it asks for your medical #. It worked for me and I've been using it to actually lower our speeds.
Thanks, might give that a try.
Question: Due to the aluminum toxicity issue with Pureflow SAK's, we told my husband's Neph that we want his aluminum level tested and she said she would order it. We do his monthly labs at home and take it to the clinic (Fresenius). The clinic then sends it to Spectra. My question is, does anyone know if his aluminum level can be tested using one of the usual monthly test tube vials or does/should it involve a whole separate vial of blood to be drawn? We normally draw "pre" dialysis: Tiger tube and Lavender and the Gold "post" dialysis. We plan on calling the center tomorrow during business hours to find out but thought I'd ask if anyone on here knows. Thanks.
You will need a separate dark blue top tube and best drawn pre-dialysis. Also, you should not take vitamins or mineral supplements a couple of days before the blood draw.
Spectra, like most labs used by dialysis centers, send the blood elsewhere to be tested. - http://www.spectra-labs.com/laboratories-test-menu#search
Anyone being told by Fresenius that they no longer test for aluminum at their center because Spectra no longer performs the test? My husband's Neph didn't know that either so wrote him a "prescription" for the test and told him he will have to take it to a lab on his own to have his aluminum level tested and...to be prepared because it could cost upward of $500. Needless to say, I am quite upset about this and concerned over the fact that this was all brought up with the Neph last month and only now are they getting around to telling my husband that their center "no longer covers/performs" aluminum tests. My husband uses the NxStage cycler and altho he did not use any of the contaminated SAKS on the Recall List, he does use SAKS and now come to find out, Fresenius never even took his baseline aluminum level when he began dialysis last September, so we have no idea what his aluminum level was before using SAKS and certainly do not know now and Fresenius will not test for it. Hhmm...
You can contact Charlonda Thrower, Patient Services Director for ESRD Network 14:
Patient Services Director
Charlonda Thrower, BA, LMSW
469-916-3808
972-503-3215 Ext. 324
email: cthrower@nw14.esrd.net
Patient and renal professional concerns/grievances
Decreasing patient conflict/Involuntary patient discharge
VocRehab/Advance care planning/End of Life
Quality control audits with results to MRB
If not familiar with the ESRD Network system, read this thread recently posted by Meinuk:
http://ihatedialysis.com/forum/index.php?topic=31444.msg475263;boardseen#new
For specific info on ESRD Network 14 which covers Texas: http://www.esrdnetwork.org/
This page gives full staff info: http://www.esrdnetwork.org/network/who-we-are/staff.asp
Thats weird because we are at Fresenius clinic and we are testing my wifes aluminum every month. No problems at all with it. We just got our latest and it was still up at 36 . She was at 44 so it is SLOWLY dropping.Question: Due to the aluminum toxicity issue with Pureflow SAK's, we told my husband's Neph that we want his aluminum level tested and she said she would order it. We do his monthly labs at home and take it to the clinic (Fresenius). The clinic then sends it to Spectra. My question is, does anyone know if his aluminum level can be tested using one of the usual monthly test tube vials or does/should it involve a whole separate vial of blood to be drawn? We normally draw "pre" dialysis: Tiger tube and Lavender and the Gold "post" dialysis. We plan on calling the center tomorrow during business hours to find out but thought I'd ask if anyone on here knows. Thanks.
You will need a separate dark blue top tube and best drawn pre-dialysis. Also, you should not take vitamins or mineral supplements a couple of days before the blood draw.
Spectra, like most labs used by dialysis centers, send the blood elsewhere to be tested. - http://www.spectra-labs.com/laboratories-test-menu#search
Anyone being told by Fresenius that they no longer test for aluminum at their center because Spectra no longer performs the test? My husband's Neph didn't know that either so wrote him a "prescription" for the test and told him he will have to take it to a lab on his own to have his aluminum level tested and...to be prepared because it could cost upward of $500. Needless to say, I am quite upset about this and concerned over the fact that this was all brought up with the Neph last month and only now are they getting around to telling my husband that their center "no longer covers/performs" aluminum tests. My husband uses the NxStage cycler and altho he did not use any of the contaminated SAKS on the Recall List, he does use SAKS and now come to find out, Fresenius never even took his baseline aluminum level when he began dialysis last September, so we have no idea what his aluminum level was before using SAKS and certainly do not know now and Fresenius will not test for it. Hhmm...
Thats weird because we are at Fresenius clinic and we are testing my wifes aluminum every month. No problems at all with it. We just got our latest and it was still up at 36 . She was at 44 so it is SLOWLY dropping.Question: Due to the aluminum toxicity issue with Pureflow SAK's, we told my husband's Neph that we want his aluminum level tested and she said she would order it. We do his monthly labs at home and take it to the clinic (Fresenius). The clinic then sends it to Spectra. My question is, does anyone know if his aluminum level can be tested using one of the usual monthly test tube vials or does/should it involve a whole separate vial of blood to be drawn? We normally draw "pre" dialysis: Tiger tube and Lavender and the Gold "post" dialysis. We plan on calling the center tomorrow during business hours to find out but thought I'd ask if anyone on here knows. Thanks.
You will need a separate dark blue top tube and best drawn pre-dialysis. Also, you should not take vitamins or mineral supplements a couple of days before the blood draw.
Spectra, like most labs used by dialysis centers, send the blood elsewhere to be tested. - http://www.spectra-labs.com/laboratories-test-menu#search
Anyone being told by Fresenius that they no longer test for aluminum at their center because Spectra no longer performs the test? My husband's Neph didn't know that either so wrote him a "prescription" for the test and told him he will have to take it to a lab on his own to have his aluminum level tested and...to be prepared because it could cost upward of $500. Needless to say, I am quite upset about this and concerned over the fact that this was all brought up with the Neph last month and only now are they getting around to telling my husband that their center "no longer covers/performs" aluminum tests. My husband uses the NxStage cycler and altho he did not use any of the contaminated SAKS on the Recall List, he does use SAKS and now come to find out, Fresenius never even took his baseline aluminum level when he began dialysis last September, so we have no idea what his aluminum level was before using SAKS and certainly do not know now and Fresenius will not test for it. Hhmm...
Yesterday we got the ok to test our actual dialystate from the sak. We are testing aluminum , and all the other levels such as potasium , sodium , etc. This will tell us if the aluminum is fixed and if the saks are actually giving the exact levels of electrolytes they claim. WE drew it yesterday and should have the results in a week. This should be VERY interesting.
On the other hand I cranked at the Fresenius people recently as I wanted them to consider doing blood work for me persoanally as the care giver/dialyzer . They make money on me doing it and we pay higher electric bills and other expenses to do it at home. I just wanted them to do something for ME , not just my wife. They basically said tough Sh--T, we dont do anything for the care giver. REAL NICE!The transplant clinic sent me 8 tubes to collect from a potential donor and ship back. Fresenius was (by policy) unable to to the sample collection, even though it was directly related to the patient's treatment.
My nephrologist's nurse (and nephrologist) could draw blood, prior to dialysis as a courtesy they drew my monthly blood for tissue matching (now quarterly). Probably this is because they are also doing the vein work so they have to be certified for that type of thing. Otherwise I found it hard to get the blood drawn, once in awhile I could get Quest labs to do it as part of another draw but no-one knew how to write an order to get blood drawn that I could take with me... The hosptial's out patient lab would do it but they charged over $75 for drawing the bood - I have insurance but that just seemed outrageous and they were not close - another reference lab would do it for $35 but only took checks and didn't bill insurance...On the other hand I cranked at the Fresenius people recently as I wanted them to consider doing blood work for me persoanally as the care giver/dialyzer . They make money on me doing it and we pay higher electric bills and other expenses to do it at home. I just wanted them to do something for ME , not just my wife. They basically said tough Sh--T, we dont do anything for the care giver. REAL NICE!The transplant clinic sent me 8 tubes to collect from a potential donor and ship back. Fresenius was (by policy) unable to to the sample collection, even though it was directly related to the patient's treatment.
Davita uses its own lab in Florida for blood tests.. We have to Fed Express our samples to them.Fresenius also uses it's own lab (Spectra). I Fedex my samples to NJ, and I think there is another Fresenius/Specra lab on the west coast.
So you might be able to ask your nephrologist if they could help if you both go in to the office for a real appointment.Went to the local hospital lab - the prospective donors insurance card worked wonders.
After a full month using hanging bags only Maggie's Aluminum level has gone from 18 down to 13 :cheer:Still on Pureflow - went down from 13 to 10 after a couple of months.
After a full month using hanging bags only Maggie's Aluminum level has gone from 18 down to 13 :cheer:Still on Pureflow - went down from 13 to 10 after a couple of months.
I should have our test results on aluminum and all other chemicals in the sak this coming week. We drew off a sample the other day. My clinic was willing to do it as my wife is still at 36 aluminum. That should give us some much needed info. I will post the results.After a full month using hanging bags only Maggie's Aluminum level has gone from 18 down to 13 :cheer:Still on Pureflow - went down from 13 to 10 after a couple of months.
Do you have the routing papers to see if it is a SAK batch made by PiSA? Some folks are still reporting high levels and others are not. I wish NxStage was upfront in relating the continued risks, but they are hiding behind ill advised K/DOQI guidelines allowing up to 10 mcg/liter of aluminum in dialysate. Fortunately for some, it appears that they are using PiSA for some of the SAKs as well.
Once again, getting some samples from the PureFlow of the completed batch for aluminum samples is something I have asked for and yet to get any responses. What are folks fearing that won't send in this simple test? I don't get it.
Well that report at lkeast indicates I was correct in not switching from the saks to the bags. It appears Nxstage has fixed the aluminum issue. I am awaiting our own results but assume they should be good too. We can all relax now. No more hanging bags for those who switched.
We are now using a Britta filter for all drinking water. I hope it filters out aluminum as we cant seem to get an answer. It does filter out most metals. We just started this last month. Hopefully it should help.
If anyone knows more about the Britta system please let me know. It uses an activated carbon and ion exchange resin to filter water. It does list copper, mercury and cadmium , chlorine and zinc as being filtered. Since non renal patients aren't harmed by aluminum it wouldnt list it anyway.
Interesting that Maggie and Jeff's Al was 5 micrograms/liter in both Saks and bags. On May 9th (before we knew of the recall) I submitted a Sak AND a Pak sample to Spectra. We all know the Pak RO system is about the best there is. However both Sak and Pak had identical AL results of 8 micrograms/liter. How can that be? I really don't think Spectra has the sensitivity/accuracy to measure AL in water or Saks or bags. We're testing blood serum AL every 2 weeks. Last result was 19, up from 12 2 weeks ago. Heard from a reliable source that all will be "resolved" by Oct. which to me means the current contaminated Sacs will all be exhausted from inventory. Now using 2 hanging bags to complete our 30L treatment. This is totally unbelievable.
Thanks for that Zach. You are right about the potassium . I noticed my wifes potassium go up from 4.9 to 5.1 since the start of the Britta. In her case its ok as she gets low after dialysis anyway (3.7) , so it actually may help. I wish I knew whether it takes out aluminum.
We are now using a Britta filter for all drinking water. I hope it filters out aluminum as we cant seem to get an answer. It does filter out most metals. We just started this last month. Hopefully it should help.
If anyone knows more about the Britta system please let me know. It uses an activated carbon and ion exchange resin to filter water. It does list copper, mercury and cadmium , chlorine and zinc as being filtered. Since non renal patients aren't harmed by aluminum it wouldnt list it anyway.
Dear Dr. O,
I can't answer your aluminum question, but you should be aware of the issue with the BRITA filter adding potassium to the filtered water.
http://www.brita.net/ae/faqs_household.html?L=24
FAQs - frequently asked questions
I am on a potassium restricted diet, is filtered water still suitable for me?
BRITA cartridges contain potassium partly due to the production process and partly from naturally occurring potassium in the activated carbon. This potassium is gradually released into the filtered water over several litres; the rate of release depends on the hardness of the water. The higher the hardness the faster the potassium is washed out.
Potassium is essential for many functions in the human body, especially for cell renewal. As it is considered to be such a beneficial mineral, there is no maximum limit for potassium in the drinking water standards. The amount of potassium in BRITA water is negligible and not relevant at all for people with normal health.
Individuals with kidney disease or those who have to monitor their potassium intake should be aware of the possible increase in potassium in the early litres of water filtered through each new BRITA cartridge and may wish to discuss this with their doctor. Contact BRITACare Customer Services for further information.
###
Please note:
I believe the above website & information is from the United Arab Emirates (UAE) BRITA website.
The American BRITA website FAQ is less forthcoming:
https://www.brita.com/using-your-brita/faqs/
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I wish I knew whether it takes out aluminum.
Zach, you are a SAVIOR. I cant thank you enough.
I wish I knew whether it takes out aluminum.
Dear Dr. O,
Here are the results on several brands of countertop water filters.
I'm not sure how reliable the web site sponsor is, so take it as you will.
http://www.naturalnews.com/046536_water_filters_heavy_metals_lab_results.html
According to their labs, the BRITA filter adds aluminum.
Note: One needs to provide an eMail address to read the results, so I added a screen shot below.
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