Sak Recall

[Maggie and Jeff]

Can the aluminum be removed via sweeting?

[Hemodoc]

Can the aluminum be removed via sweeting?

Yes, but not as efficiently as healthy kidneys, but sweat, urine, liver and feces are the routes of elimination of aluminum. However, excessive sweating in some dialysis patients may not be healthy.

[Hemodoc]

Here is the article from the Boston Globe. There are several folks here on IHD that were contacted by the Boston Globe reporter. The article covers some of the basics, but I would have liked to have seen a better investigative report. In the end, we haven't learned anything new from the article.

http://www.bostonglobe.com/business/2014/06/11/recall-fluid-used-home-dialysis-shocks-worries-patients/kUHgQHt90pw7OHx95PebSJ/story.html

[Speedy1wrc]

If NxStage wanted to keep it on the DL that idea is toast.

I'm just glad the word is out.

It was pretty soft however.

[caregivertech1]

So many unanswered questions for NxStage. Glad the article was written and thanks to those who participared. Still can't believe no lawsuites.

[Hemodoc]

So many unanswered questions for NxStage. Glad the article was written and thanks to those who participared. Still can't believe no lawsuites.

Lawsuits literally take years. That does not mean there won't be any in the near future. There is usually a 5-7 year statute of limitations. It takes time to find all the information a lawyer needs under discovery. That is just one more flawed aspect of her article.  Even the title is dismissive in itself. Good grief, patients are "upset." Patients get upset when they have to wait 10 minutes. I would state that this goes beyond upset by a wide, wide margin. To say the least, can we trust this company any longer.  Did they put profits ahead of patient safety? What caused a company with an excellent safety record to go to a company where the patients have serious doubts about continuing with this company? Where was the sentiment reflected in her article. And then to end with a financial analyst that states we have no choice. Good grief. Terrible reporting.

[Dannyboy]

Yes, the article left many questions unanswered.  I hope it is the start of more details forthcoming.
One point in the article that was news to me is that "140,000 to 150,000 units" were recalled.  That is a lot of SAKs. 
Hopefully NxStage will disclose the total number of treatments made with recalled SAKs, but I guess that would have to wait for legal discovery from what I'm hearing above.
Also discussed here:
http://ihatedialysis.com/forum/index.php?topic=31234.0

[caregivertech1]

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.

[Hemodoc]

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.

No, NxStage will not come anywhere near that in the future. Lessoned learned so to speak from top ranking corporate officials at NxStage that I spoke with about a week ago. I will finish up a post for my blog soon after I have had a chance to get feedback from a few different companies with associations to NxStage. I suspect all will either not respond or choose no comment. NxStage will not comment until the FDA report and investigation is completed due to regulatory constraint. But they do want to tell the story when they can.

But yes, the K/DOQI guidelines of 10 microgram/liter definitely are way too high.

[Hemodoc]

Here is my first post on Hemodoc for over a year on the NxStage aluminum issue. I hope this answers SOME of the questions surrounding this event. The final story will not be written without disclosure from NxStage after the FDA report is finalized. I cannot claim credit for this story since I came upon this information from an anonymous source who wishes to remain that way. I don't use confidential information in any of my posts since I have no legal department as a safety net so this is as far as I can take this story at this time. I look forward to the completion of the FDA report. This continues to be a significant event in many ways that needs full disclosure to prevent any similar or like occurance in the future.

http://www.hemodoc.info/2014/06/nxstage-aluminum-contamination-is-rockwell-medical-at-fault-1.html

Please note that my URL has changed to www.hemodoc.info. All prior posts can be accessed with the new URL.

[obsidianom]

I want to be the first to write, EXCELLANT BLOG/ARTICLE . You gave us what the newspaper article missed. At least we have a target now to look at in terms of whom is to blame. Its too bad the news paper didnt take the oportunity to go into the same depth, it may have helped a lot.
So thank you Hemodoc/Peter for getting your blog going again and writing about this issue we all dealt with .
In the end my only goal and concern is that this never happen again, no matter who is to blame. My wife still has very high aluminum levels. It was 44 last month. In 2 days we will see the latest. So we were effected a lot.
I still beleive in Nxstage and will continue to use it and support the company. I dont however trust Rockwell. I wont let my wife use their new drug, Triferic.

[caregivertech1]

Ditto...Thank you Hemodoc.

[PrimeTimer]

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.

[Hemodoc]

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.

Thank you again, but as noted above, this is not really my story.  There is more to the story, but from public records, this is all I could confirm.

As far as quality control, I will be writing a follow up article on the quality control issue. That will add a bit more to the picture, but until we have the FDA records, i don't believe we will be able to confirm all the details of this event from what is in the public record.

I did talk to the VP in charge of quality control and I do believe NxStage will make the necessary corrections in quality control especially when they outsource to other companies.  We will wait and see, but the folks I spoke with at NxStage, while not divulging details unknown to the public, did assure me that the FDA has a good working relationship with NxStage and they felt confident that the process will meet all "specs" and that their product will continue on the path it had previous to this event. I take them at their word at this point in time.

[Dannyboy]

Thanks for the link/blog posting.  Can't wait for "the rest of the story".

[Speedy1wrc]

More of "the ret of the story".

I spoke with an official at NxStage as well. While we have assumed that these lot's slipped through the cracks, they didn't. We wondered how they could either not be testing or have missed that the aluminum level was high. Well get ready to be really angry because they did know the aluminum was high. And they knew it a year ago.

I was told that they, " didn't forsee any issues with upstream contamination". Yup, they knew about the problem and made an active decision to ignore it. Are you seething yet? I asked how could they do that, and the answer was that since they didn't have any reports of elevated aluminum levels or any reports of symptoms, they decided it wasn't a problem. Now you're spitting nails right? I told him that I know that was false since we reported several patients using SAK's as opposed to bag's who had dramatic and sudden elevation of aluminum levels. I will quote my nurse, she said "I was freaking out at them about this". I was promised that he would go back and find out what happened back then and get back to me. I am still waiting.

We all are wondering what NxStage is doing about this. In terms of the affected patients. Don't hold you breath, because they are doing NOTHING. Over and over I asked this and the answer I got every time was, "talk to your center". I said that they weren't the ones responsible for making us sick and the stonewalling kept going. Over and over, "talk to your center". I specifically asked what about long term problems, those which we can't predict at this point, and the answer was still the same.

the conversation was over the phone and while not in person, I do honestly believe he was stunned that there were patients who are sick. I think they stuck their head in the sand with this and I think I triggered a run down the hall to say, hey fella's we have a problem. He promised me that he would tell ME what has been done from a product standpoint to fix this. I told him back that they needed to tell everyone, not just me. That caught him off guard I felt. He said he would look into it and get back to me. I stopped holding my breath awhile back. I haven't heard from him since. I have a fw hours to kill tomorrow morning and I shall give him a call back to let him know I am not dropping this.

I made it clear that there were a lot of very upset patients and many who were showing distinct symptoms. I didn't get any apology, but he was served notice that they indeed have a problem they will need to deal with. I also let him know that this wasn't a whisper quiet discussion but that it was exploding over social media and they really needed to deal with it. Once again I was promised action. Yeah right.

I too am very upset. I have many symptoms and to put it bluntly, they made me sick.

[Hemodoc]

Wow, if confirmed that changes things significantly. That is not good news. Thanks for the update. I didn't get any of that sort of information from the folks. I did ask them how they missed it and why it wasn't picked up in post production testing. Wow. That is not good. If that is in the FDA report, NxStage will take a big hit. Not good.  I was planning on doing a follow up post on the NxStage quality control failure. Looks like I have a lot more homework to do. Wow. If they knew and didn't take corrective action, that really opens them up to liability. Wow. That is perhaps the worst information about this whole mess I have heard yet.

[iolaire]

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.

[Dannyboy]

Wow.  Speedy, no doubt you made notes on WHO you talked to, etc.


If the statements made to Speedy are owned up to by NxStage publicly, I can hear the NxStage "spin" coming here.....  "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]...' "


I can hear echoes of the Late Senator Howard Baker (during the Watergate Hearings)....[as if to NxStage]: "What did you know, and when did you know it?"


This thing is getting smellier by the day...and yeah, pisses me off big time as I too, have adverse symptoms.

[Speedy1wrc]

I don't know what will happen next. On the NxStage Users group on FB it has grown legs. Patients are now coming out and speaking up. Hopefully that will elicit some sort of reaction from NxStage.

[Simon Dog]

"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.   

[Hemodoc]

"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.

Being in "spec" is not enough. K/DOQI says 10 mcg/liter is fine. Well, it isn't. I spoke to Joe Turk and he used that term, all products today are "in spec." I didn't consider it at that time, but that is not actually reassuring to me. Purac produces products at 0.11 mcg/liter. 10 mcg/liter is a hundred times greater than the best lactate producer in the world. I hope and pray that NxStage is using the best producer of lactate. If not, I am DONE with them. Maybe not tomorrow, but done when I have an option I consider viable.

[Speedy1wrc]

"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.

[Hemodoc]

"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.

True and not good.

[caregivertech1]

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.