Sak Recall

[Hemodoc]

Yup, and they are only used in the ICU setting for continuous dialysis regimens in the critically ill. They do not use them with the home patient population. I know, I asked due to their lower sodiium levels quite recently.

[Bill Peckham]

Bill:

The bicarb-based PAKs are a two stage design which requires mixing before use.  Shelf life is not the issue.  Nxstage profits are.

The current lactate SACs have a 96 hour shelf life, the bicarb system needs to be used as soon as it is made.

[Zach]

From a letter to NxStage patients:

UPDATED* Voluntary Medical Device Recall SAK Dialysate Concentrate
SAK-301, SAK-302, SAK-303, SAK-304, SAK-305, SAK-306, SAK-307, SAK-407

May 15, 2014

Dear NxStage Customer:

Description of Problem

NxStage Medical, Inc. has confirmed through internal testing that specific lots of SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification. NxStage Medical, Inc. was made aware of the issue through customer complaints indicating an increase in the serum aluminum levels of patients over a one year period identified during routine, annual blood tests. There have been no adverse health consequences or medical interventions reported.

The NxStage SAK concentrate, a component of the NxStage Pureflow SL module, is intended to contain the essential electrolytes, buffer, and glucose in the appropriate concentrations that when proportioned with purified water produces dialysate. The NxStage Pureflow SL module is an optional accessory to the NxStage System OneTM that prepares dialysate for use during hemodialysis, as prescribed by the physician.

The affected products and lots can be found in Attachment A.

The affected lots were manufactured between April 2013 and February 2014.

Potential Risk

NxStage Medical, Inc. initiated an extensive investigation and confirmed that specific lots of sodium lactate, a raw material used in the production of the SAK dialysate concentrate, contained levels of aluminum which would exceed specification when the concentrate was fully diluted.

There have been no adverse health consequences or medical interventions reported. Specifically increases in patient serum aluminum levels averaging 10μg/L have been reported within specific dialysis networks. The aluminum levels of the affected lots range from 11.5 μg/L to 13 μg/L when the concentrate is fully diluted. The product specification requires concentrate aluminum levels to be less than 10 μg/L. NxStage believes that the likelihood of any serious adverse health consequences is remote at the serum aluminum levels currently reported. NxStage has confirmed that other SAK lots in distribution meet the specification for aluminum levels.

The complete letter:
http://ww2.nxstage.com/rs/nxstagemedicalinc/images/NxStage%20Recall%20Notice%205%2015%202014%20Updated.pdf?mkt_tok=3RkMMJWWfF9wsRokuq%2FJZKXonjHpfsX56ugqXaS2lMI%2F0ER3fOvrPUfGjI4DTMFkI%2BSLDwEYGJlv6SgFSrjEMbhiybgFWRE%3D

[Hemodoc]

I am quite disappointed in the NxStage letter implying that the levels of aluminum in patients will only be about 10 with the normal level up to 9. Not true, mine two months ago was over 20. Sorry, but not happy with this whole episode. Where is their quality control that patients have to tell NxStage that there is a problem Houston. That is NOT the way it is supposed to work.

[obsidianom]

Read this article fully about aluminum and its effects in dialysis patients.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3524902/

[obsidianom]

This shows that bicarbonate dialysis can also cause aluminum issues.


Kidney Int. 1995 Aug;48(2):469-74.

Epidemic aluminum intoxication in hemodialysis patients traced to use of an aluminum pump.

Burwen DR1, Olsen SM, Bland LA, Arduino MJ, Reid MH, Jarvis WR.

Author information

Abstract


This study was designed to identify the source, risk factors, and clinical consequences of an outbreak of aluminum intoxication in hemodialysis patients using case-control and cohort studies. In 1991, a dialysis center in Pennsylvania [Dialysis Center A (DCA)] identified a number of patients with elevated serum aluminum levels. All patients receiving dialysis at DCA during January 1, 1987 to March 26, 1992 were involved in the study. A case-patient was defined as any patient with a serum aluminum level > or = 100 micrograms/liter after > or = 5 dialysis sessions at DCA. Fifty-nine case-patients were identified. Risk factors for elevated serum aluminum levels were receipt of bicarbonate- (rather than acetate-) based dialysate, higher number of sessions using bicarbonate dialysis, receipt of acid concentrate (used in bicarbonate dialysis) passed through one of two electric pumps, and a greater number of sessions using this concentrate. The electric pumps had an aluminum casing, casing cover, and impeller. Elevated levels of aluminum were found in acid concentrate after passing through a pump. Seizures and mental status changes requiring hospitalization were associated with aluminum exposure. We found that epidemic aluminum intoxication was caused by the use of an electric pump with aluminum housing to deliver acid concentrate used in bicarbonate dialysis. This outbreak demonstrates why it is essential to insure that all fluid pathways, storage tanks, central delivery systems, and pumps are compatible with low pH fluids before converting from acetate to bicarbonate dialysis.

[obsidianom]

I am quite disappointed in the NxStage letter implying that the levels of aluminum in patients will only be about 10 with the normal level up to 9. Not true, mine two months ago was over 20. Sorry, but not happy with this whole episode. Where is their quality control that patients have to tell NxStage that there is a problem Houston. That is NOT the way it is supposed to work.

11.1 To prevent aluminum toxicity, the regular administration of aluminum should be avoided and the dialysate concentration of aluminum should be maintained at <10 µg/L. (EVIDENCE)

11.1a CKD patients ingesting aluminum should not receive citrate salts simultaneously. (EVIDENCE)

11.2 To assess aluminum exposure and the risk of aluminum toxicity, serum aluminum levels should be measured at least yearly and every 3 months in those receiving aluminum-containing medications. (OPINION)

11.2a Baseline levels of serum aluminum should be <20 µg/L. (OPINION)

[obsidianom]

Remember this from last fall? She had high aluminum and didnt know why. Now we know.

Angiepkd
Full Member

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    High aluminum
« on: November 08, 2013, 09:30:52 PM »   

--------------------------------------------------------------------------------
Hi all!  For the last 3 or 4 months my aluminum level has been climbing.  This month it is up to 30.  I have stopped using antiperspirant, checked my lotions and make up and quit cooking with aluminum pans.  Nothing seems to help.  When I spoke with my nurse today she told me they have several patients whose aluminum levels are elevated, and the doc can't figure it out.  Anyone else have this issue with NxStage?  I use a SAK 303.  Not sure what to do to get those levels down.  Thanks for any help!   
 

[Hemodoc]

My nephrologist put me on Zinc supplements to help against the high aluminum levels a couple of months ago. If NxStage is reporting that the average level was "10" then we already have two outliers here on this thread alone. I don't believe we have seen the full depth of this horrible event. Where was their quality control since this STARTED last April. I didn't start on Pureflow until July. With a successful quality assurance program, theoretically, I should have never been exposed to this 3 months after the problem began. Instead, I have endured 10 months of exposure to aluminum and the horrible side effects of aluminum well described in the literature. NxStage needs to NOT white wash this issue. That letter I believe is misleading and could give patients false reassurance when in fact, they may be at risk. This is one person NOT happy at all with NxStage at the current time and I am not the least bit tempered in that opinion by this letter.

[slipkid]

Hemodoc, you express my sentiments quite well.  Among the many questions I have are (1) "likelihood of any serious adverse health consequences is remote," claims Nxstage.  What adverse effects (even seeming minor ones as Nxstage might define it) have been reported?  What physical and mental symptoms have been reported that should be monitored and addressed?

Question (2) is why is there any aluminum in the SAKS AT ALL?  Sodium lactate in its chemical form contains no aluminum ions.  How the hell did the aluminum get into the lactate to begin with?

As I have written before, an FDA investigation is called for to get to the truth that Nxstage has yet to reveal.


 

[Hemodoc]

Hemodoc, you express my sentiments quite well.  Among the many questions I have are (1) "likelihood of any serious adverse health consequences is remote," claims Nxstage.  What adverse effects (even seeming minor ones as Nxstage might define it) have been reported?  What physical and mental symptoms have been reported that should be monitored and addressed?

Question (2) is why is there any aluminum in the SAKS AT ALL?  Sodium lactate in its chemical form contains no aluminum ions.  How the hell did the aluminum get into the lactate to begin with?

As I have written before, an FDA investigation is called for to get to the truth that Nxstage has yet to reveal.

Absolutely. The PAK issues recently, this and the fact that they have too high a sodium level that the head of "solutions" for NxStage a couple of weeks ago didn't seem the least bit interested in addressing leads me to wonder how much longer NxStage will be in my future. I am expecting a more robust company response. If not, then they will not be my choice any longer at a minimum.

[slipkid]

Hemodoc:

Again, you have expressed my feelings about Nxstage and continuing the use of the Nxstage therapy system.

[slipkid]

I have reviewed the Nxstage product recall letter which is addressed to CUSTOMERS of Nxstage.  I am a patient associated with a Davita clinic.  Davita is Nxstage's customer.

I see no reason why I am obligated to fill out and SIGN the "Recall Reply Form" they have attached to their recall notification.

I will discuss the ramifications of this form with my attorney on Monday, however, I foresee that he will reach the same conclusion as I have  noted above.

[Hemodoc]

I have reviewed the Nxstage product recall letter which is addressed to CUSTOMERS of Nxstage.  I am a patient associated with a Davita clinic.  Davita is Nxstage's customer.

I see no reason why I am obligated to fill out and SIGN the "Recall Reply Form" they have attached to their recall notification.

I will discuss the ramifications of this form with my attorney on Monday, however, I foresee that he will reach the same conclusion as I have  noted above.

Yup, same here.

[Zach]

I am really saddened and outraged by what my friends here at IHD are going through with regard to this NxStage fiasco.
This problem with aluminum in some of the dialysate concentrate SAKs has been going on since April 2013. How has it taken this long for the folks at NxStage to figure this out?  Is there no continuous quality control?

 

[Angiepkd]

Wow! Thanks for the message to check out this thread, Obsidianom!  I hadn't paid attention to this particular thread because it was about a recall, and I received a transplant 10 weeks ago.  It makes me so angry that no one at DaVita mentioned this to me.  Everyone kept accusing me of using something containing aluminum that I wasn't telling them about.  I had my water tested multiple times, quit using antiperspirant, checked my cosmetics and lotions and never could figure it out. My neph even took me off of the sodium bicarbonate because of an association between baking soda and high aluminum.  My levels did come down, but were still above the recommended numbers.  I am wondering if I should have my aluminum levels tested now that I have a new kidney.  I was still around 17 prior to surgery, and aluminum isn't checked at my transplant clinic.  Any opinions on this?  I am also going to call my dialysis nurse on Monday to make sure the other patients with high aluminum were notified of the recall.  I can't remember any specific symptoms (which may be a symptom?!) but since I was pretty new to D, I wasn't sure if the things I experienced were normal for people on D.  I will speak to my transplant neph about this when I see him in June.  Thanks again, Obsidianom!

[slipkid]

@ Zak:

Let me add to your understanding of the aluminum contamination in the Nxstage dialysate.

The Nstage recall letter - which Hemodoc has pointed out is quite misleading -  claims that, "The product specification requires concentrate aluminum levels to be less than 10 micrograms per liter."

The operative language is "concentrate aluminum levels to be less than 10 micrograms per liter."  The issue is why is there ANY aluminum in the concentrate (the SAKs) at all?  Nxstage claims the Pure Flow system delivers ultra-pure dialysate which is mere company propaganda.  "Pure Flow", in fact, does NOT deliver contaminate-free dialysate.  The published list of elements and compounds in the SAKs by Nxstage make no mention of aluminum contamination.  It is also likely that the dialysate bags also contain aluminum contamination.  What other contaminates, metal or otherwise are contained in the Pure Flow concentrate SAKs or the bags?

I have been using the Pure Flow system for 18 months, and I have experienced side effects which were reported to my neph many months ago.  Others have been using the Pure Flow system or bags for many years.  What consequence to exposure to aluminum has been caused?  What symptoms of exposure to aluminum toxicity have we been living with that have been dismissed  by the professionals involved with our system of treatment?  My own blood tests of excessive aluminum in the blood was either overlooked or ignored by my neph.

The issue of aluminum contamination is somewhat analogous to the mesothelioma debacle (asbestos exposure).  Patients exposed to asbestos were not diagnosed with the disease until decades had passed after exposure.   Post mortem autopsies of Alzheimer patients have revealed aluminum in the brain.  It is theorized that exposure to aluminum contamination has caused the latent or early onset of Alzheimer's.  Are patients using the Nxstage therapy faced with a similar fate, notwithstanding any present side effects we may be experiencing?

I trust this gives you a better understanding of why some of us are furious with Nxstage (and others for that matter).



 

[Dannyboy]

How is 'Serum Aluminum' listed on my lab results listing?
I don't recognize anything with 'Aluminum' in it?

I' ve been using a  bunch of the recalled SAKs.

[obsidianom]

How is 'Serum Aluminum' listed on my lab results listing?
I don't recognize anything with 'Aluminum' in it?

I' ve been using a  bunch of the recalled SAKs.

In most clinics it is only done once a year or every few months. It has to be specially drawn and ordered. Ask your nurse to draw it. It should just say aluminum.

[Dannyboy]

Hmmm.   I will request a specific Aluminum test tomorrow (Monday) from my Davita nurse.
Thank you obisdianom.

Like others here, I'm pissed/dismayed over this situation.  Plus, Davita hasn't contacted me about this (got the news here and in an email from NxStage).   The NxStage letter sure downplays this issue.

Will be interesting to see when their SEC filings comment on this (none so far as I could find).  The degree to which *NxStage* will acknowledge potential negative financial impact will be interesting too, as a possible indicator of how "big a deal" this will turn out to be.

(Interestingly a Senior Vice President of NxStage just unloaded around $60K of common stock on Thursday (he still owns much more)).

---Dan

[Zach]

For those who may be interested:

NxStage Medical, Inc. 2014 Annual Shareholder Meeting
Thursday, May 22, 2014 - 10:00AM EDT
Held at the Lanam Club:
260 North Main Street, Andover, MA

DIRECTIONS to the Lanam Club:
Continue on Route 93 North through Boston to Route 495 North (Exit 44A) (approximately 15 miles). Once on Route 495 North, take the Route 28 South / Andover exit (# 41). At this point, the Lanam Club is 1 mile ahead on the right. Parking is on the side of the building. Please use the Main Entrance in the front.

You can contact NxStage Medical, Inc.'s Board of Directors to provide comments,
to report concerns, or to ask a question, at the following address:

Corporate Secretary
NxStage Medical, Inc.
350 Merrimack Street
Lawrence, MA 01843

SEC Filings
http://ir.nxstage.com/sec.cfm

 

[Bill Peckham]

How much aluminum is in incenter dialysate? In city water? We take for granted that the saline is saline and the heparin is heparin but no one actually knows. In the heparin case it turned out that the Chinese pig intestines used to make heparin was tainted early in the procurement process. In this case, one of the inputs was adulterated. Pointing at stock sales and alleging company malfeasance is a stretch.

The alternative is not peeing, the alternative is, for most, incenter, conventional hemo. In a unit an aluminum wrench fell into the dialysate tank and everyone was dosed with aluminum that way. We are all relying on averages, on average the water is x or the dialysate is y. No one is checking the dialysate that is used at the station, when it has been checked as part of due diligence for one study or another it has been constantly found to vary widely from the prescription.

No matter which machine you use at home or incenter, you are relying on manufactured inputs. The lesson here is to be more suspect of the process. What should bother the dialysis units is their reaction when their patients had an elevated aluminum. Instead of harping about aluminum foil ?! better to first check the dialysate.

We’ll know units are applying this lesson if people who are having trouble with thirst (aka sodium) first have their dialysate checked before being given the sodium lecture. Again.

[Zach]

We’ll know units are applying this lesson if people who are having trouble with thirst (aka sodium) first have their dialysate checked before being given the sodium lecture. Again.

So true, Bill.

The dialysate level a dialysis machine reads, say 14.0, and the actual level may vary greatly.
 
That's why when I was doing self-care at my center, we always checked our machine before each treatment with a conductivity meter.

When centers don't independently verify the dialysate level, patients could be unnecessarily cramping during treatment (due to a low dialysate level) or become terribly thirsty after treatment (too high a dialysate level)--and be blamed in either case for those results.

 

[Speedy1wrc]

One hundred percent false that no adverse symptoms were reported to NxStage. Mine were. My nurse noticed a drastic increase in my Al levels from when I began home hemo till an aluminum test last Spring. We went through the whole list of possible sources including testing my tap water multiple times. There were no indications of any other external sources other than the dialysate. In addition she noticed the exact same response in another patient also using the Pureflow. Her other patients using  bags did not have the same elevated Al levels. In all cases the labs were drawn at the same times and sent to the same lab for analysis.

She contacted NxStage with her concerns about the dialysate and was told it was not possible that it could be contaminated. NxStage knew there was a potential for contamination as early as June of last year and did nothing about it.

I have been experiencing severe memory loss and an overall malaise since last Spring when I started with the Pureflow. I am incensed that NxStage "apologizes for any inconvenience"  due to this incident. I also think that the list of affected SAK's is woefully misleading. I truly believe the number is much higher. If I were to guess, those lot's were identified only because they had examples to test. I suspect there were many other lot's which were also contaminated but there is no data.

I am also contacting a lawyer.

[caregivertech1]

Here's our "inconvenience".  Al level went to almost 30 last July. Bought all new stainless steel cookware, stopped using everything that contained aluminum, went to bottled water for drinking and cooking, went back in center twice for a month each time which reduced level to 10.....only to go back to 25 when  we returned home to contaminated sacs. Only Nxstage users experienced this since last Summer. Duh? Couldn't get my nurses at Fresenius to even think about the saks. Unbelievable!!