Sak Recall

[amanda100wilson]

I am pretty sure that NxStage could not get data from Spectra, since this would be breach of confidentiality laws.

[Hemodoc]

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.

If some of the recent allegations made show that NxStage KNEW that the aluminum levels were elevated and continued use of the product, then that is going to be an fatal offense in my opinion. What I am now worried about is that I have heard that the current SAKs are "within specs." Does that mean that we now have levels less than 10 mcg/liter but still greatly elevated beyond Purac's -0.11 mcg/Liter that they produce? If so I am done with this company.

[Speedy1wrc]

When I spoke to NxStage I jumped all over their assertion that they knew about the problem a year ago. That didn't fly with me. I don't think they expected the anger. I came right out and asked how they could know about this and continue to poison us. I think at that point is when the wall went up and I stopped getting answers.

DaVita does aluminum quarterly after a baseline at the start.

Caregiver Amanda and I also reported high aluminum back before the supposed recalls. I think we all suspect its been going on longer than admitted.

We may find out soon if the SAK's are any "better". Hopefully they are. We are investigating that now.

[Dannyboy]

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

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.

• 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.

***end FDA clip****

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

[Hemodoc]

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

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.

• 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.

***end FDA clip****

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

This is simply a summary of the last 3 months of FDA recalls if I remember correctly from a few days ago. In any case, it is a summary with no new information since the NxStage notifications.

I believe that we do know the underlying mechanism of aluminum contamination in the lactate dialysate. I am unable to go further because NxStage will not confirm at this time the exact mechanism, but I am convinced by circumstantial evidence alone that Rockwell new to the manufacture of lactate products did NOT use Purac. I can state that because Purac recently sent me a reply stating that they are NOT involved in this FDA recall, but Purac would not confirm who there clients are per long standing policy. But interestingly they DID state that they were not involved in this. Purac manufactures lactate products, pharmaceutical grade at 0.1 ppm (.11 mcg/liter) aluminum purity. That compares to the diluted aluminum contamination of 11-13 mcg/liter in the SAK. Note, that prior to diluation, this would be SIGNIFICANTLY higher in the concentrate.

The source of lactate that I heard from which I have heard from anonymous sources is the source of the PiSA bagged dialysate and previously the concentrate is Purac. That is why until Rockwell, we never had any difficulty with aluminum. I am not able to confirm this information publicly from any spokesperson at PiSA, NxStage or Rockwell and Purac won't divulge their clients either. But that is unconfirmed confidential information I cannot use as a source in a story because I don't use confidential information for any of my articles.

So, yes, we do know what happened in reality. Purac was the producer of our lactate for the dialysate and still is for the bags. That is why they are not involved. If I can ever find a source in public records or a company representative that will confirm any of this information, I would be more than happy to write it up. But I don't use single source information ever. But I am convinced by circumstantial evidence that this is the case but I won't go with a story on this as such. One source is not enough to make an accusation so at present I am treating this as a rumor I have heard only. Is it likely true, I don't print rumors on my blog so I can't do anything with that information other than help me know what to look for. I believe it is so, but I can't confirm it yet with a second source, so at this point it is not above the level of a rumor. That is not enough but hearsay which is not acceptable evidence I can use.

Rockwell I believe is the key, but I can't find the smoking gun to nail it directly to them accept by circumstantial evidence alone. Purac did state categorically that they are not involved and I can use that publicly. We know that Rockwell who is contracted to make the SAK concentrate did NOT use Purac. That we know from a publicly proven source by email a few days ago from Purac.

The real question comes down to the quality control at NxStage. Who knew and when did they know? I believe there are some interesting answers to that which I can soon print as well. I believe NxStage KNEW that their product had high aluminum and went and sold that product anyway. That is a TERRIBLE indictment.

[slipkid]

As I understand your theory, the source of the lactate used in the premixed bags and concentrated SAKs, prior to Rockwell’s involvement, was Purac.  Am I to understand that Purac manufactured the lactate with an aluminum level 100 times better than the minimum ANSI/AAMI standard at an undisclosed plant (presumably in the US) and shipped by tanker truck this lactate to Mexico where it was used to make the concentrated SAKs, and the remainder diluted to make the premixed bags? Alternatively, were two shipments, one of the concentrated lactate and one for the premixed bags made by Purac?

Premixed bags, uncontaminated, and contaminated SAKs in my possession all have made in Mexico printed on them, so it appears that PiSA, and possibly another firm, were involved with the manufacture of the premixed bags and SAKs.

However, Purac’s involvement strikes me as a peculiar theory given the fact the PiSA is a pharmaceutical manufacturing company and may be capable of making sodium lactate on its own. This would also seem to confirm why, “Purac recently sent me a reply stating, Purac would not confirm who there(sic) clients are per long standing policy.”  Do you know with certainty from your anonymous source that Purac had any involvement with PiSA within the last year and a half?  If they did not, it would explain why Purac was quite willing to offer that they had no involvement with the recall.

You claim that, “The source of lactate that I heard from (which I have heard from) (sic) anonymous sources is the source of the PiSA bagged dialysate and previously the concentrate is Purac”. Earlier you claim that, “Purac manufactures lactate products, pharmaceutical grade at 0.1 ppm (.11 mcg/liter) aluminum purity. That compares to the diluted aluminum contamination (emphasis added) of 11-13 mcg/liter in the SAK.”  What do you mean that this “compares to the diluted aluminum contamination of 11-13 mcg/liter in the SAK?”  Are you not confusing what is allegedly produced by Purac with Rockwell?

I am also confused that a Nxstage representative stated earlier in this thread that the dialysate is now “within spec.”  What spec is this? The 0 .11 microgram per liter limit (Purac), or the ANSI/AAMI standard of 10 micrograms per liter (likely PiSA)?
 
You chastised me in a different thread for not revealing my source.  I suggest you look to your own use of anonymous sources as to what you have suggested regarding the Purac- PiSA connection. You state, “So, yes, we do know what happened in reality. Purac was the producer of our lactate for the dialysate and still is for the bags. That is why they are not involved. If I can ever find a source in public records or a company representative that will confirm any of this information, I would be more than happy to write it up.” (emphasis added)

[Hemodoc]

An anonymous source outside of NxStage relayed this information. I can't use that as anything more than a rumor at this point on my blog. No, anonymous source no matter how sincere are just that. I do not believe that PiSA is involved in this, BUT, I can't get a direct phone to a pr person and I can't get a question through on NxStage on their contact page. My information PRIOR to Purac stating that they were not involved is that Purac was not involved. It is confirmation of what I was told, but it is not enough as you state to treat my information as anything more than a rumor at this time.  My gut feeling is that it is the correct information.

NxStage has their own plant in Mexico as well from my understanding. I may be wrong on that and don't have the time or the inclination to look up that information again, but that is my understanding.

So, I do believe that in the end, this will be the correct path for what occurred.

If I offended you in a prior post, I apologize. That was not my intent. I just believe that what I was told from a source outside of NxStage is likely credible. I have heard other "rumors" as well. I only mention this rumor since it seemed to pertinent to the ongoing discussion. There are other rumors I have heard that I cannot confirm as well. I only write in my blog that which I can confirm by various sources. I wish we had those sources right now, but after a very diligent search, it remains an unconfirmed rumor and I am posting this and the last post as such.

As far as "in spec." Yes, that is a great worry for me as well. 10 mcg/liter is WAY too high for aluminum in dialysate. That is what I was told by  NxStage administrator and that statement bothers me greatly. Someone was going to have their current SAKs tested for aluminum to see exactly what it is right now. That is information we need to have.

Sorry again if I offended in the other discussion on your anonymous source. It is simply that the information you provided conflicted with what I have heard from unconfirmed sources. Until we are able to hear the direct details from someone in the FDA, Rockwell, Pisa or NxStage, we will remain much in the dark. That is how I am treating the rumors I have heard. I did talk to two folks at NxStage in high administrative positions and I asked them about all of these issues but neither would confirm or deny any of it. That is the best I can do at this point. If you don't trust "this rumor," that is fair enough. That is why I didn't write it up in my recent post on HemoDoc. I do believe we deserve a full explanation and soon, but I won't hold my breath waiting for an answer from any of these folks any time soon. I hope I am wrong about that, but that is also my gut feeling especially with the new pr campaign NxStage recently launched.

Take care,

Peter

[Speedy1wrc]

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?

[amanda100wilson]

I use  Pureflow.  My Aluminium has been fine.  I did use some of the affected SAKS.

[Hemodoc]

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?

I am in total agreement. The SAKS allow me better supply control but not at the expense of continued high aluminum. I cannot understand the thinking by NxStage. They don't appear to have learned their lesson yet and that is an expensive lesson on our part. We need a healthy home hemo market. We now have two, we need more to bring about increased access through market competition. I don't see any other way we will increase utilization for home hemo without that aspect. I don't want to see the demise of NxStage, but they are not making good decisions today.

[Dannyboy]

Interesting.  My Aluminum has dropped (but still high)  since discontinuing the recalled SAKs of which I used a bunch.
I have a prejudice against bags, 'cause they seem to take more time/effort to set up, etc. 
However if the SAKs are "infusing me with unreasonable amounts of Aluminum", that is of course another story.

Should have most recent Labs today, curious to see Aluminum level.  In my case I have no "baseline" as it was never checked until the recall.  Sounds like it will be hard to go much below 10 (with Pureflow) from what I'm reading here in this thread.

--Dan

[Hemodoc]

My aluminum levels are up today to 16 from 14. Not dropping. I am sick of this baloney. My Hb is down to 9.5 which is the lowest it has ever been. I am close to needing another dose of iron in the next month as well, but certainly, my levels have changed dramatically as far as how long they last. I believe the aluminum is part of the problem.

I am now approved for bags for the next 6 months. I am getting an emergency shipment this Thursday, so hopefully, no more PureFlow at least until they correct this horrible problem.

I am VERY disappointed in NxStage, VERY. They are just one more for-profit  dialysis corporation.

[caregivertech1]

I also firmly believe these "in specs" sacs currently in use will result in elevated Aluminum. On 6/17 our aluminum dropped from 20 to 13, then on 7/8 it was up to 17. As I have posted, our aluminum averaged over 20 from Sept. 2013 to Jan. 2014 without using any recalled sacs. These sacs were probably within their 10 microgram limits but infecting my wife to unacceptable levels. 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.

[caregivertech1]

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.

[Angiepkd]

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 was not aware of any direct correlation between high aluminum levels and liver disease in NxStage patients.  This is very interesting, as I have both Polycystic kidney and Polycystic liver disease.  I would be curious to see some statistics comparing elevated aluminum levels in patients with liver disease to those without liver disease. Maybe the docs will weigh in on this?

[Speedy1wrc]

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.

[obsidianom]

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 think this is all about exposure to aluminum and body size. My wife is tiny so her levels are higher.
 

[Speedy1wrc]

Since you mentioned it, I spoke with someone the other night who said their husbands aluminum was 56.

[Speedy1wrc]

OK, more data in. Not only did going onnbags lower my aluminum, by I got my other labs back today. My Hgb jumped 2 to 12.3.

It's a done deal, no more Pureflow.

[Hemodoc]

My aluminum is 16 and my Hb is 9.5. Lowest ever. I hope and pray it goes back up. I am getting IV iron next week. Aluminum prevents hematopoiesis,  which is the bone marrow making blood cell process. It also hinders iron absorption from the GI tract. That is a double hit causing the anemia. My iron levels dropped dramatically in the last 4 months. That is much more so than ordinary.

NxStage no longer deserves our loyalty and trust. In fact, they rank worse than DaVita and FMC in my mind at this point. FMC with the Granuflo incident did make corrections and their product they use today is not hurting folks. We cannot say the same about NxStage essentially lying to us that everything is now fine but it ISN'T Shame on you Joe, shame on you. Say it ain't so Joe, but it is.

[PrimeTimer]

This is all pretty upsetting. They never took a baseline reading when he started dialysis this past fall but my husband is going to insist on having his aluminum level tested NOW. Fortunately, we did not have any of the bad SAKS but the whole issue and the level that IS allowed is upsetting. May be a dumb question but what about their new "S" cycler and doing larger volumes??? Would that mean the more volume, the more aluminum??? Hanging 4 bags on an IV pole and having 1 bag on the warmer is bad enough but how about those needing more than 25 liters per treatment?

[Hemodoc]

I have used 40 liters since my second month on NxStage at home. Yes, more dialysate, more aluminum.

[PrimeTimer]

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...

[Hemodoc]

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.

[PrimeTimer]

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.

I agree!