Sak Recall

[Hemodoc]

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

NxStage users now called  Home Dialysis United has had commercial support from NxStage for their conferences and a VERY close working relationship with them through Rich Berkowitz and Joe Turk at NxStage. I am not surprised that they are silent on the issue, but I doubt that Rich would have been silent. He always spoke out against anyone anywhere that endangered dialysis patients.

 HDC likewise has industry support. I place a post on Dialysis Discussions Unlimited but it didn't last long.

Renal support network has huge ties to the industry.

RenalWeb sells ads to NxStage and Medisystems. They have not gone as far as they should have to date either.
AAKP, NKF, RPA are all industry supported.

That is one of the reasons why IHD is such an important site. However, I would venture to state we have not yet heard the end of this. There is much more to this story to come and hopefully soon. Dr. O has done a great job looking into some of the connections. I am waiting to hear from NxStage and to see how they respond now and in the future. If they go into whitewash mode, then my relationship as a patient and advocate will be over.

The Baxter machine is NOT portable, but has some very interesting features. It is likely the next one on the market. If NxStage wants my support, it is important for them to take a leadership role in this whole mess and set things straight and in complete transparency. To date, they have not given us the details on the who, what when and where in the process this event occurred.

If they choose to hide behind their statements in the voluntary recall which has not declared all of the lots since many had symptoms and elevations of aluminum BEFORE the reported April 2013 notifications, then I would not be least bit surprised if someone else digs up the real story to their embarrassment even further.

NxStage is a direct competitor of FMC/DaVita and other although they are in agreements with them for the home market. It will not take too much to get their competitors to open up on NxStage especially given that FMC has it's own portable machine in development and pending FDA approval. 

In any case, it is up to NxStage to take the bull by the horns or sit back and let someone else do it for them. The first way will indeed be painful, but could save their reputation. JFK faced the end of his presidency with the CIA led Bay of Pigs invasion. I am convinced that JFK was not really on the inside of that operation and it was just forced upon him by an out of control CIA. However, JFK stood up, took full responsibility and is one of the aspects of his presidency that he did well in my opinion.

I believe that is what NxStage needs to do in toto.  Will they? We shall wait and see. That will give us all the message of whether they are going to truly be the dialysis advocate that they have portrayed their company, or whether they are just another business as usual for-profit dialysis corporation. Time will tell us soon which one they are.

[obsidianom]

My wife is stiiting next to me hooked up to the Nxstage machine as I write this. For the first time in 2 years I am uncomfortable with it.
My wife put it perfectly when i hooked her up and she said to me " I dont anymore if while I am on this machine I am being helped or HARMED."
That really hit me. WE both used to feel safe on it.
Its like being married and having your spouse have an affair. You can never trust them again. (at least I wouldnt)  . Trust has been lost now. How can we ever trust Nxstage again?.  They have violated our trust and not handled it well in the aftermath. They really didnt even apologize. It was more of a "well we made a little mistake but dont worry about it and try to forget it and move on" .   I would expect a lot more after what occurred but so far they havent been very contrite.  They want our trust but did nothing so far to earn it back.
Yes the aluminum is an issue. BUT THE FAR BIGGER ISSUE IS TRUST, AND FUTURE FAITH IN THEM TO MAKE A SAFE PRODUCT.  How do we ever trust them again. This time it was aluminum. Next time it could be endotoxin or other poisons like cyanide (that was noted in the Rockwell violation, lack of testing for cyanide). Or just simply not having the correct levels of the chemicals that are supposed to be in there such as potassium and sodium and calcium etc.
Their quality control is highly suspect so HOW DO WE TRUST WHAT WE ARE GETTING NOW ?
Well I put this out to Nxstage . You need to win back our trust folks. I suggest you get to it NOW!!

[obsidianom]

Please read my thread on General discussion  PLEASE READ , BY DR. O.
I have added several new posts that are interesting . Rockwell is all over and working with Nxstage.   
I hadnt realized that Rockwell acttually produces the raw acid and bicarbonate for Fresenius and Davita. They are HUGE.  They tested Triferic on in center patients in the dialysate and when it is finally approved will have it put in the dialysate in center to many patients.   Remember their filthy violation filled plant in SC.  They are more scary then Nxstage . Of course now Nxstage is in bed with them. WOOOPEEEE!!!!

[MooseMom]

I was about to post the same sentiments shared by Karen.  I had gone so far as to redesign and adapt my entire basement for NxStage equipment and supplies as, after years of research, this was the modality that I'd chosen for myself.

I'd always believed that NxStage were the "good guys" in an industry where "good guys" are few and far between.

I've been following this thread for many days and am really disappointed that the news seems to be worsening.

I agree with everyone that trust has been violated, and if you can't trust the various people who are supposed to be working to help you survive this devastating illness, weel, it's devastating.

[Simon Dog]

What is lacking, and would help, is a commitment from NxStage that all future batches will be chemically analyzed to make sure that all parameters are within specification.   In other works, quality control at the Jack Daniels level.

[Speedy1wrc]

NxStage's silence is deafening.

[obsidianom]

On the 8th day God created EPO. On the 9th day Rockwell created Triferic to replace it.  On the 10 th day the patients became anemic again. oops!

[Hemodoc]

 For future reference, oral absorption of Aluminum almost NEVER takes place. It is by direct membrane contact from a water source. The aluminum binders were the scapegoat back in the 80's for aluiminum caused dementia, however, at that time they were not using RO systems. In the fallout of that report, aluminum binders took the hit and then folks were placed on calcium binders which increased the risk of heart disease and cardiovascular calcification.

Here is a VERY interesting article revieiwing this issue:

http://www.biomedcentral.com/1471-2369/12/20

One aspect that is terribly troubling fromt his article is that because the aluminum becomes protein bound, the levels in the patient are 3-4 fold HIGHER than in the contaminated fluids. We have much left to learn about this entire debacle.

[caregivertech1]

The next step will be how to remove the aluminum. As I mentioned in an earlier post my wife went incenter(FMC) twice to do that. The first time, with a level of 25, we were on the F200 dialyzer which filtrates larger molecules 3 times a week for 3 weeks. We went back home with a level of 12 which is still high. At home we went back to 28 (don't know for sure yet about the lot numbers). So we went back in the center with the F180 dialyzer for another 3 weeks. This time we went back home with a level of 10. At home we trained on the cartridge 124-C which is packaged without a dialyzer. This is a real bear to prepare. You hang 3 saline bags and install your own dialyzer..in our case the F180. After 6 days the AL was 17 and at the end of about 3 weeks it was 20. The very day we ended this test NxStage fessed up with the recall with affected lot numbers.....You guessed it, the 124-C with the F180 test was run with a contaminated SAKs. Thanks NxStage for sitting on this info while we working like hell to remove the AL. I tested this batch (and the PAK H2O)used before the letter came out. A NxStage rep and my center came to our home and tested it again after the letter came out. No results yet. The samples went to 2 labs. Not sure the current cartridge(170-C with attached dialyzer) will remove this AL. As another post indicated the AL combines with protein which is probably larger than the middle molecules they advertise can be removed. So now we're back to the 124-c for a week now with a starting level of 20 and hopefully non contaminated SAKS(who the hell knows). We'll sample again in 2 weeks. Stay tuned.

[Zach]

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

The recall is mentioned on the Facebook page of NxStageUsers:
https://www.facebook.com/groups/nxstageusers/

It's just that most of the comments were made around May 15th-17th.
And Facebook keeps moving postings and comments down the timeline as newer topics are posted.

Here is Bill's posting:
Bill Peckham
May 15 at 5:07pm · Seattle, WA
There has been excess aluminum in some SACs manufactured in the last year, There was a recall announced today, check with your unit for effected SAC numbers. Everyone should get their Aluminum checked
~~~~~~~~~~

You'll see lots of posts and comments below Bill's post.

Here is Hemodoc's post on the Facebook page for Dialysis Discussion Uncensored:
https://www.facebook.com/groups/DialysisUncensored/


Peter Laird
May 15 at 12:59pm
Everyone on NxStage at home using the PureFlow should contact NxStage and their centers. There is a voluntary recall of PureFlow due to high aluminum levels. Mine have been elevated for the last 3 months, now I have an answer.
~~~~~~~~~~~~~~~~

Unless these posts have recent comments, they stay all the way down on the timeline.
A poster may also have the ability to "pin" the comment to the top of timeline, but not always.

 

[Speedy1wrc]

Cartridge 170-C will have no effect on the aluminum. That is what I have been using all along and my aluminum is currently sitting at 20.

I am going to talk to my Dr about going in center using the F180. The sooner I can get my aluminum down the better.

[caregivertech1]

So here's the question Speedy. Does the 170-C remove the aluminum and your contaminated sacs are putting more back in at the same time ? Don't believe lot numbers on the recall list are aluminum free. What a mess.

[Speedy1wrc]

That's a good question, it is entirely possible. I tried to look up cartridge characteristics last night and came up empty handed. I truly believe there were many more affected !of numbers than were disclosed. My aluminum and other patients was high before the recalled lots.

[obsidianom]

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.

[Maggie and Jeff]

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.

Well said.

We are having an AAMI run on both the sak and the hanging bags so we can pick the least contaminated mix.

[caregivertech1]

Please post the results when available. Tks.

[Maggie and Jeff]

Please post the results when available. Tks.

Will do.

[Dannyboy]

How frequently are we supposed to be checked for serum Aluminium?   looks like some are tested every few months, others every 6 or 12 months...... Is it more a policy-type thing, rather than a "required" by somebody test?
For me,I can't find that I've EVER been tested for serum Aluminum, both In Center and home with NxStage.   Gonna request the info from the Neph next visit.
PS: oh yeah, I used a bunch of the recalled SAKs.
--Dan

[obsidianom]

I am asking for monthly aluminum for the next few months until I am satisfied this is all cleared up . I dont trust anyone right now . Better to test and be aware then have it sneak up on you.

[Simon Dog]

My clinic tests annually in January.    I was just tested because of the SAK issue (came in at 13) an dam scheduled for a retest in 3 months.

[Speedy1wrc]

Is this post being moderated?

Yesterday I posted about my conversation with NxStage and now it's gone.

[Maggie and Jeff]

I never saw it speedy maybe you should try again.

[Speedy1wrc]

Holy cow. I spent over an hour yesterday writing it. I posted it and checked and it was there. I was wondering why I didn't get any email notifications about any replies. I don't have time today to re-do it.

My conversation with NxStage was an eye opener. I will say this, if you haven't already push your center to relay your concerns, lab results and symptoms to NxStage. As some have wondered, nothing is going on right now on their end.I will provide details when I have time to compose another post darn it.

[Hemodoc]

Actually, I just got called by my dialysis use today. She had  NxStage survey with several questions SHE had to complete. The questions were on MY diet, antiperspirant use, and binder usage. What does that tell you about NxStage and who is going to claim responsibility for these issues? I am going to get a copy of the survey later today.

[Speedy1wrc]

I'm a bit surprised that came from NxStage. From my conversation with them, they have no plan in place to address patient concerns or symptoms. Their plan is to leave it up to centers to attend to any problems. When I spoke to my center (Davita) for their part, their only course of action is to monitor aluminum on a monthly basis.

So hopefully this post doesn't get erased.

I spoke with the Senior VP of Customer Experience at NxStage and boy was it an eye opener. I started by asking why it took a year for them to notice this problem. He said that they in fact do test every batch. He said they did know about the problem with the sodium lactate but didn't see any significant upstream contamination (quote). I pushed him to give a reason why knowing there was a problem that they still shipped the product. He said that they don't hear that there were any problems from the centers. I told him that we reported a problem (me) as far back as April and he acknowledged that there were a few isolated reports of elevated aluminum levels but that they were relying on the centers to determine the causes. I then told him we went through all the proper steps and determined it had to be the SAK's but they declined to admit it was their problem. He vowed he would go back and review what transpired at that point. It was clear that they have moved on and had no plans for any further action.

He asked me what he needed to do and I said they had to regain the trust of the patients as many of us are very angry. He said he would provide me with what they have done to fix this, to which I answered, they needed to publicly address the concerns of all the patients, not just me. He promised me he would be talking to the head of their regulatory group and get back to me. I did get the impression he would follow through on this.

I brought up the issue of patients with multiple symptoms and what they intended to do to help them. Either they really didn't consider that there could be a problem or they are stonewalling. Here he disappointed me. He deferred to the centers to take care of any problems. No matter how I pushed him, he kept deferring to the centers and Dr's. I hit him hard asking about those of us with more serious problems that didn't necessarily have "cures" and he yet again threw it back to the centers. They are deflecting pretty much everything.

In (only) my opinion I feel that they were not expecting nor were prepared to hear there were problems. He claimed that they were relying on feedback from centers to determine if there were problems. He claims they only got reports of a few isolated cases and expected the centers to find the problems elsewhere. If you haven't already, push your center to relay your symptoms and aluminum levels to NxStage.

I probably forgot something. If you have any questions, I'll try to answer them if it's something we talked about. I'll keep you posted on what I hear.