Sak Recall

[Speedy1wrc]

I've been searching for any information about this recall and did find some interesting information. I ended up at the FDA site and there are an amazing number of entries for NxStage. They are both recalls incident reports. There are currently 1530 incidents listed in their database.

Some curious things I gathered. As I suspected some "product" is manufactured not in the US but in Mexico. So no surprise at the lack of quality control. But a common theme is saw in a handful of incident reports was blame being laid on the patient/user/operator. Many of the case were labeled as no cause found, must be operator error. I am seeing a theme with the way the PAK issues were (not) handled and how the mindset is at NxStage.

I also browsed the latest SEC filing and there was a lot of laying the foundation for failure. If this then scenario's.

I do not have a good feeling about any of this.

[slipkid]

@ Speedy:

I would appreciate a link to the FDA page where you found the Nxstage incident reports.

I have been contacted by a member of the forum about a class action lawsuit and a party that is willing to listen.

Have you?

[Speedy1wrc]

Just go to fda.gov. There is a search box where you type in NxStage. On the list of results it will first show recalls. Below that will be adverse events. Make sure to click on more results like this.

I too was contacted about a class action suit. I don't know who it was that sent me the email. The site it sent me too seemed somewhat legit but not enough to give me warm and fuzzy feelings about it. My lawyer is a personal friend so I will wait to see what he thinks of this whole thing.

Who will be the first to contact CNN?

[slipkid]

Found the FDA adverse event database.  Thanks.

[obsidianom]

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.

[Maggie and Jeff]

We have had issues with high aluminum for at least 18 months.

[Speedy1wrc]

te author=obsidianom link=topic=31141.msg481995#msg481995 date=1400578675]
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.
[/quote]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.

[Maggie and Jeff]

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.

I agree.

In addition to the aluminum we have had high magnesium and can't find the source.

[obsidianom]

High aluminum will cause hyper calcemia AND HYPERMAGNESIUM. So the magnesium is probably from the aluminum. My wife has high magnesium and high calcium.

[Speedy1wrc]

In center my phosphorus was normal on 2 binders per day. My magnesium was low and aluminum was normal. Starting on NxStage my phosphorus jumped as did aluminum and magnesium.

[amanda100wilson]

My first thought when I first became aeare of this recall.  Anecdotal evidence was brought to NxStage's attention for over a year.  Where was their random sampling for quality control before and during this time?  Why was this not identified by them?  Once they were being made aware of this problem, why wasn't the source identified sooner?

[Hemodoc]

Actually, it was FMC that conducted a study of home PD, Home NxStage, Other home hemo and in-center patients showing that NxStage patients since mid 2013 had markedly elevated levels.  Not yet broadcast, but that is what happened.

[Angiepkd]

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.

[cariad]

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.

[Hemodoc]

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.

Not quite Cariad. Chelation is standard therapy for elevated levels of aluminum in dialysis patients, but higher than what is being reported at present.

http://emedicine.medscape.com/article/165315-treatment

[Angiepkd]

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!

[Speedy1wrc]

It's controversial may best, but there is suggestion of using hair samples.

[Hemodoc]

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!

Measuring actual damage is not going to be an easy task. Adynamic bone disease is one side effect, but how many folks want a bone biopsy AND it is a risk for dialysis patients to begin with. Memory loss is subjective. Blood levels are certainly the easiest to obtain.  I have yet to hear of anyone with a level higher than 30 which means few would have need chelation with dexferoxamine.

I know subjectively, that since starting on the PureFlow last July, I have NOT felt as well as usual. Can that be related specifically to high aluminum levels? Not an easy task to measure objectively.

The unknown is what is the long term sequelae from this type of exposure over several months? I would venture that little is known on such an exposure at this point. The studies on aluminum exposure in dialysis patients are over two decades old when related to aluminum containing phosphorus binders.

Nevertheless, this entire episode is simply unacceptable. We will see how NxStage responds, but to date, I am not happy with this turn of events.

[Speedy1wrc]

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. 

[Bill Peckham]

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.

In addition I think there is an assumption that people who use dialysis aren't going to live long enough to have impacts 20 years hence.

[Hemodoc]

The entire issue boils down to what quality assurance protocols does NxStage have in place. Obviously, there was a failure in manufacturing but that was NOT picked up by quality assurance in a timely manner. In fact, it appears to have been an external agent, FMS, that found the high aluminum was from NxStage patients alone. That in itself is a failure that NxStage will need to correct if they wish to regain confidence in their product.

With the entire issue of oversized PAK's which I just had another one two days ago that didn't fit and now this SAK issue, that is two fundamental product lines that are not subject to proper post marketing quality assurance BEFORE going to the consumer. How long before a manufacturing issue results in deaths instead of ill defined aluminum accumulations with poorly defined objective measurements of end organ damage or PAKs that don't fit. The harm of the aluminum is a difficult issue to define due to lack of studies, lack of objective end organ assessment and most likely lack of proper follow up by any agent keeping data in a universal data base of all affected. That is likely not going to occur since NxStage is the only one with that data base and it is not likely that they will follow each individual case. They have already referred us back to our individual units. What follow up studies will they do to see if there are any adverse effects from this episode? FMC, DaVita and DCI are the only agents that have the ability outside of NxStage. Will CMS follow this or the FDA? Shucks, I expect it will simply be white washed and cast away.

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?

We will see how they respond, but at present, my level of confidence in this company is at a very low level. We will see how they proceed.

[caregivertech1]

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]

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.

[caregivertech1]

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.

Hey, I know what you're saying. I too should have yelled louder or done more but at the end someone did listen....too late but you know what, it's over and just maybe NxStage will learn from this and we can again trust them.

[Bill Peckham]

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.


There are good reasons to go one way or another with the machine you choose to use, but product integrity shouldn't be one. We live in a world of incredible complexity these aren't cases of malfeasance as much as shit happens, and near as I can tell shit happens everywhere. There needs to be some final quality check at the chair that could pick up some of this but in the end when a dialyzor experiences unexpected results we should suspect a device/process failure.