Sak Recall

[Maggie and Jeff]

I'm wondering what those AAMIs will show.........and now you have me wondering what NxStage will say about the results especially if they are not good results.

  I am praying that it's not bad   

I'll share the info  if the results are good       

But if things are bad    we'll need to do what we can  work together and get our message out 

[KarenInWA]

There is a thread on the NxStageUsers Facebook page. I'll put the post and comments here but will leave out the names. Wondering what you all think of what is being said here...

Original Post: Has everyone gotten their aluminum test results? Mine is high and we'll be taking them several more times. Since this incident, I've had shortness of breath and the distance I can comfortability walk has decreased. Now Doc is sending me to heart Dr. Not bad to get things checked out, but was wondering if anyone else was having issues. Of course they told me there were no reported complications from the aluminum ...

Comments:

 - We were told that Aluminum Toxicity would be anything over 40-60. How high is yours?

 - Just under toxicity level .... according to them

 - We are getting my husband's test done this week.

 - Mine are elevated

 - <Glad I use only bags at this point> Sorry for those of you exposed to this aluminum issue with the Pureflow saks.

 - Paul's Alluminum was good, but we are now on 405 SAKS for the last little while so I guess that was a good thing

 - Glad we are doing bags instead of pureflow as well.Hope everybody comes out ok with these issues.

 - I called about hubby's results today but was told they had to send them away somewhere!?

 - Make sure they tell you your aluminum levels!

 - Ron's came back as 46 -- pretty upsetting..

 -  I got mine today. It's 20. I was told normal is between 0 and 10. When they told of the recall, I didn't have any of the SAKs but I must have in the past year.

 - That's probably it <above poster>, we wouldn't have known we had any but two boxes (from two separate recalled lots that were shipped to us) didn't get rotated with the others & weren't used yet...that means we used a bunch a couple months ago! Still waiting for aluminum results!

 - Wow <person who stated Ron's levels>, with it being that high, what is the protocol?

 - Mine is 31. They told me they consider toxcity at 40 to 60 for dialysis patients. Linda they should give him the chelate at 46.

 -  I went online to look since nobody else had an answer and sure enough it was there! His is 23 but I'm sure it was probably higher when we were actually using the SAKs 2 months ago.

 - Thanks for the info - I wasn't with him when he got this info, He is going in next week for another blood draw. Someone there told him that number wasn't very high - in fact they said that 200 wasn't to high . I'll have to do more checking.

KarenInWA

[slipkid]

Here is a 2 page letter from Davita's chief medical officer regarding the aluminum contamination issue.  Note the date of the letter and the paragraph on the second page which states that 10 micrograms per liter is the "lower limit of precision" of their test.  My blood test report notes an acceptable range of 0-10 micrograms per liter.

The question mark on the second page was added by my neph.

[obsidianom]

our nephrologist is concerned with any number over 20 . She feels this is the cutoff for any potential danger. She is older and remembers the issues with aluminum back in the early 1980s.  WE had ours drawn yesterday . WE will see.

In addition our nephrologist gave me a copy of the latest "Up to Date "  printout on aluminum toxicity and treatment. One thing stood out.   "EXCESS ALUMINUM DEPOSITION IS UNLIKELY IN PATIENTS WITH BASELINE SERUM ALUMINUM CONCENTRATIONS UNDER 20 MC/L."   
In other words over 20 is BAD and aluminum begins to deposit in bone and organs.  A word to all . Watch out if your number is over 20.

I disagree with Davita on this based on what my nephro and the 2013 guide I just read . Davita claims over 40 as the cutoff. They quoted a 2005 paper. My up to date guide claims 20 is the magic number. So beleive what you want but I dont trust Davita as they would probably have to deal with more fallout if they dropped the number . My number comes from non financially involved sources.

[amanda100wilson]

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.

[Dannyboy]

Thanks slipkid for posting the Davita letter.   Interesting.

My Aluminum came in at 27 this month.    Wish there was more of a medical consensus on what level is a serious problem.   My Davita unit doesn't regularly check for Aluminum it turns out.....mine was previously checked in 2011 (!)...[it was 6 at that time].   Not sure if it is their policy or if they were/are just being lazy/overlooking/too busy to  be testing for aluminum more frequently.

Received replacement SAKS from NxStage yesterday via UPS (to replace recalled boxes). 

[Speedy1wrc]

While it seems we have become strictly statistics, let's not rest comfortably as such.

My levels have been in the 20 range and I am definitely suffering symptoms. I am not following the trend I guess.

From reading an article in the Telegraph a woman died of complication of dementia. Her serum aluminum was 28. The complete autopsy report is forthcoming. Post mortem brain tissue results show aluminum in the 20-30 range for many subjects diagnosed with Alzheimer's.

You can find many data sets and depending on which side of the problem you are on can determine which sets you use.

The second letter above states no symptoms have been reports and in a sense I may agree with that. Unless a nurse/patient team is actively pursuing a cause for a symptom it could easily just be brushed aside. For example I was dealing with dry skin all Winter. It was easy to write it off as dry air. But it still continues and only now going back seeing when it started does it start to make sense. The metallic taste was reported to my team, but lacking any sense that it was/caused by a systemic prblom it just gets filed away. Now is the time to start looking at symptoms over the last year to determine if there is any correlation.

As for what NxStage should, they should pro actively be involved with determining if anyone was harmed. From what I garnered from my conversation was, hear no evi,l see no evil.

I did forget something from my conversation. He did say that they would continue to work with their providers to ensure product compliance.

[Hemodoc]

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.

Well, NxStage has many duties and obligations in their fiduciary responsibilities to all of their patients.

1) Complete disclosure on exactly WHAT happened and WHY.

2)  Monitoring of all patients potentially affected for any adverse future events with compensation for any that occur.

3) Compensation for anyone harmed by their product right now.

4) Improvement of the quality control systems so that this or other problems do not occur.

These are just some that come to mind off the top of my head, but NxStage has much yet to do.

[Simon Dog]

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.

[Hemodoc]

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.

In your case, proving harm would likely not result in a successful case. However, there are many with levels over 30 and 40. If harm has occurred, then yes, NxStage SHOULD compensate them.

Individual lawsuits are notoriously difficult to prove with 90% going in favor of the practictioner.  Class action lawsuits are a different story.

[Simon Dog]

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.

[obsidianom]

I hate lawsuits and lawyers. WE didnt even sue when the surgeon screwed up my wifes stomach and left her on a feeding tube for life. Maybe we should have as it was a clear cut horrible result but we chose to accept "shit happens" and move on without the stress of a lawsuit.
A certain doctor in another country who was informed about the aluminum issue has in no uncertain terms told me we should move on , accept the mistake , and stop making so much out of it. That doctor just doesnt like the American mentality of suing for every mistake.
Now I am not saying I am not royally ticked off by this . I AM.    But my first and formost goal is getting the company to make sure it NEVER happens again or any other mistake like this . I want to stay with Nxstage and still beleive in their system . I want them to improve their quality control and be more careful in the future.
I still beleive there is a bigger problem out there as I have posted numerous times about . It involves another company and their new drug for dialysis patients, questionable facilities and coorporate mindset . They have a lot more effect on all dialysis patients then Nxstage. They could be involved in the Fresenius recall of contaminated dialysate solution. I dont know if they are but I have my suspicians. We will see.

[Speedy1wrc]

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.

[Maggie and Jeff]

Dialysate AAMI came back >.005 aluminum in both the Sak (lot 40379185) and the hanging bags.  All other #'s were in range.

[Angiepkd]

I spoke with my transplant doc today about the high aluminum levels I had while using NxStage.  I asked if I should have my aluminum levels checked now, post tx.  He did not think so, as my new kidney would be filtering any aluminum.  If I push the issue, I am sure I can get him to order the test, but was wondering what you all thought?  He had not heard of the recall or the aluminum problems, but he deals only with transplant patients, so I can maybe understand that.  However, he does work in the same office with several other docs who deal with dialysis patients, including my primary neph who tried to help me figure out the source of my aluminum.  Wouldn't there be some type of communication there?  There are several NxStage pamphlets in the waiting room, but nothing about a recall.  I am curious if my dialysis clinic has anything posted about it.  I may call my D nurse Monday and ask her if her patients were notified.

[Speedy1wrc]

Every patient on NxStage should have received a packet from their center and also one directly from NxStage.

[caregivertech1]

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.

As of June 2nd my wife's level was still 20. Neph says it's probably in the tissue and will take time to gradually remove it. Just recently went to 30L(from 25) which extended out time on the cycler to over 3 hrs. which should help.

[obsidianom]

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.

[Angiepkd]

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. 

[Hemodoc]

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.

Yes, it is treatable with Desferoxamine chelation. Here is an article showing reversal of microcytic (small cell) anemia with that treatment.

http://www.ajkd.org/article/S0272-6386(87)80058-6/pdf

[Angiepkd]

Thanks, Hemodoc!

[Speedy1wrc]

I just texted my nurse and found my aluminum is down to 17. Better than before but still high. My HgB jumped up a tad too.

I have free time on Friday and I think I am going to stretch my treatment out to see if I can "clean" myself out better.

[obsidianom]

What are you doing to lower it?

[Speedy1wrc]

Actually nothing. I am assuming the dialzer is removing some. I have no residual kidney function, so they're not helping. I'm not sure I am otherwise excreting any aluminum?

[Hemodoc]

Serum levels of aluminum are notoriously inaccurate. Tissue samples usually from the bone secure the diagnosis. I don't believe I will volunteer for that test.  A surrogate marker is microcytic anemia (small cell). If the serum levels are improving and the anemia is improving, the serum levels may in fact be telling. But once again, serum levels do not reflect the aluminum in the tissues.