Sak Recall

[Simon Dog]

I am willing to bet they had a specification for aluminum and were relying on their vendor to ensure it was meeting specification.

I believe that every batch of beer is tested for alcohol content before shipment, and I expect Jack Daniels does some quality control before it bottles its stuff.   It would seem to make sense to test the lots of solution for conformance to spec before packagiing them.

[Speedy1wrc]

Speedy, the dates of Rockwell's involvement need to line up with your onset of symptoms in late February or March 2013. If there product was not involved until May, then that doesn't explain your earlier involvement.

We need more information before we can draw clarity on this.

Agreed, and by calling I wanted to see what they had to say. They could easily say they did what they were expected to do. But we all have a lot of questions and right now few answers. It's time to get answers.

[Speedy1wrc]

I am willing to bet they had a specification for aluminum and were relying on their vendor to ensure it was meeting specification.

I believe that every batch of beer is tested for alcohol content before shipment, and I expect Jack Daniels does some quality control before it bottles its stuff.   It would seem to make sense to test the lots of solution for conformance to spec before packagiing them.

I agree wholeheartedly! Everything they ship out the door should be tested as thoroughly as possible and then some.

[Hemodoc]

Speedy, the dates of Rockwell's involvement need to line up with your onset of symptoms in late February or March 2013. If there product was not involved until May, then that doesn't explain your earlier involvement.

We need more information before we can draw clarity on this.

Agreed, and by calling I wanted to see what they had to say. They could easily say they did what they were expected to do. But we all have a lot of questions and right now few answers. It's time to get answers.

Absolutely and it is NxStage that owes us that explanation.

[obsidianom]

My wife had 11 contaminated cases.  Nxstage just admitted it to us.
Last fall after 6 of them she had trouble walking for 2 months and I had to hold her everwhere she went . I couldnt leave her alone . It scared the hell out of us as we didnt know why. Now we do.

[PrimeTimer]

Idea: In addition to treatment logsheets, I like to keep the receipts of the delivery invoices from NxStage...they include Lot Numbers on them. For some reason the delivery drivers they contract with didn't have a copy to give me this past month but, luckily I still had a copy I could print out from their email notifying me of delivery date/time.

[obsidianom]

NXSTAGE

NXTM » Topics » Manufacturing

These excerpts taken from the NXTM 10-K filed Mar 16, 2009.

Manufacturing


 The manufacture of our products is accomplished through a complementary combination of outsourcing and internal production. Specifically, we manufacture our System One Cycler and some PureFlow SL hardware, and assemble, package and label our PureFlow SL disposables within our facility in Fresnillo, Mexico. We manufacture components used in our System One cartridge assembly, and assemble the System One disposable cartridge and some blood tubing sets, Medics and transducer protectors in our facility in Tijuana, Mexico. We manufacture our dialyzers in our Rosdorf, Germany facility. We outsource the manufacture of premixed dialysate, needles, some blood tubing sets and some PureFlow SL hardware.
 
 

 We have a molding facility in Modena, Italy, which molds components used in the products we manufacture ourselves in Tijuana, Mexico, as well as supplies the molded components for finished goods manufactured by Kawasumi Laboratories, Inc., or Kawasumi, as described below.
 
 

 We have single-source suppliers of components, but in most instances there are alternative sources of supply available. Where obtaining a second source is more difficult, we have tried to establish supply agreements that better protect our continuity of supply. These agreements, currently in place with several key suppliers, are intended to establish commitments to supply product. We do not have supply agreements in place with all of our single-source suppliers.
 
 

 We have certain agreements that grant certain suppliers exclusive or semi-exclusive supply rights. We contract for the manufacture of the majority of our finished goods of ReadySet blood tubing sets and all our needles from Kawasumi, headquartered in Tokyo, Japan, with manufacturing facilities in Thailand. The current agreement with Kawasumi for the manufacture of blood tubing sets expires in January 2010. Under the terms of this agreement, we supply Kawasumi with molded component parts and Kawasumi in turn uses these components to manufacture finished goods blood tubing sets, which are then purchased by us. We have committed to purchase from Kawasumi a minimum quantity of blood tubing sets over the term of the agreement. We believe that this minimum purchase commitment is less than our anticipated requirements for blood tubing sets.
 
 

 We also have an agreement with Kawasumi for the manufacture of needle sets. Virtually all of these needle sets rely on our patented guarded needle set technology. In February 2007, we agreed with Kawasumi to extend their needle set supply agreement through February 2011. We have committed to purchase from Kawasumi a minimum quantity of needle sets over the three-year extended term of the contract. We believe that this minimum purchase commitment is less than our anticipated requirements for needles.
 
 

 In January 2007, we entered into a long-term supply agreement with Membrana pursuant to which Membrana has agreed to supply, on an exclusive basis for a period of ten years, the capillary membranes that we use in the filters used with the System One for ten years. Membrana has agreed to pricing reductions based on volumes ordered and we have agreed to purchase a base amount of membranes per year. The agreement may be terminated upon a material breach, generally following a sixty day cure period.
 
 

 We purchase bicarbonate-based premixed dialysate from B. Braun Medizintechnologie GmbH, or B. Braun, and our lactate-based premixed dialysate from Laboratorios PISA, or PISA. We have a supply agreement with B. Braun that obligates B. Braun to supply the dialysate to us through 2009 in exchange for a minimum purchase commitment, which we believe is less than our anticipated requirements. The contract may be terminated upon a material breach, generally following a 30-day cure period. Our supply agreement with PISA terminated at the end of 2008. We are currently purchasing products from PISA on a purchase order basis as we negotiate a new agreement with PISA.

[obsidianom]

March 8, 2013

Rockwell Medical Signs Supply Contract With NxStage(R) Medical

WIXOM, MI -- (Marketwire) -- 03/08/13 -- Rockwell Medical (NASDAQ: RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis, announced that it has signed a contract with NxStage® Medical, Inc. to manufacture dialysate concentrate for the NxStage System One™, the first and only truly portable hemodialysis system cleared for home use by the U.S. Food & Drug Administration. The contract term is for two years.
 

[obsidianom]

March 8, 2013

Rockwell Medical Signs Supply Contract With NxStage(R) Medical

WIXOM, MI -- (Marketwire) -- 03/08/13 -- Rockwell Medical (NASDAQ: RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis, announced that it has signed a contract with NxStage® Medical, Inc. to manufacture dialysate concentrate for the NxStage System One™, the first and only truly portable hemodialysis system cleared for home use by the U.S. Food & Drug Administration. The contract term is for two years.

Thi is the date of announcement only. They could have started much earlier!!!

The premix solution is made in Italy at lab PISA . This was found in SEC filing p51 of 121

They have maufacturing facilities in Mexico, Italy, and Germany

[obsidianom]

I read the whole 121 page annual report from Nxstage for 2013 . They curiously dont mention the Pureflow system or the concentrated dialysate. They do outsource a lot . They get the premixed dialysate from Italy through a contract outsource.   
They have facilities in Mexico , Italy and Germany. In GERMANY they make the dialyzers for themselves and Asahi corp. In Mexico a lot of the system is built. They seem to have 2 locations in Mexico.
They were sued by Gambro in Massachusets court in 2012 and settled out of court in 2014.
I still think it is Rockwell making the dialysate but it is curious they dont make any mention of that part of the system anywhere in the annual report. They make it sound like it is all premixed dialysate.
 
Here is a thought . Perhaps they left the Pureflow out of the annual report BECAUSE THEY KNEW LONG BEFORE THIS THAT THERE WAS A PROBLEM WITH THE DIALYSATE.  They signed off the annual report on 3-3-13.  That means they left out a major ccomponent of the system in the report ,only wrtiting about the premixed dialysate, because PERHAPS they knew there was a problem in 2013 or very early 2014. Long before they admitted it.
I read ther report twice through the best I could . I couldnt find ANYTHING about Pureflow or dialysate concentrate. Only premixed dialysate.

Lawsuit gambro
http://dockets.justia.com/docket/massachusetts/madce/1:2012cv10370/142392

[obsidianom]

Immediate Past CMS Chief Medical Officer Joins NxStage Board

Former Centers for Medicare & Medicaid Services (CMS) Chief Medical Officer Barry M. Straube, MD, joined NxStage Medical's Board of Directors, the company announced in July. Dr. Straube, who also directed CMS's Office of Clinical Standards & Quality, retired from the agency in February 2011.

While at CMS, Dr. Straube and his office spearheaded several key initiatives, including national quality improvement collaboratives, quality measurement and information technology efforts, the development of value-based purchasing models, and implementation of the Affordable Care Act, NxStage noted in a news release. Dr. Straube also chaired the End-Stage Renal Disease (ESRD) and Clinical Laboratory Open Door Forum and acted as a senior advisor to the agency on issues related to ESRD and transplantation.

NxStage's System One is a portable hemodialysis system cleared for home use by the Food & Drug Administration.

© 2011 Lippincott Williams & Wilkins, Inc.


Investment in NxStage Medical
 Further strengthening of strategic alliance

May 9, 2012
 Asahi Kasei Medical Co., Ltd.

Asahi Kasei Medical and NxStage Medical, Inc. of the US have concluded an agreement to further strengthen their strategic alliance in the field of hemodialysis which began in May 2009. As part of the reinforcement of the strategic alliance, Asahi Kasei Medical has taken an ownership stake in NxStage Medical through the conversion of all outstanding principal and interest of a loan to NxStage Medical into newly issued shares.
 
In May 2009, Asahi Kasei Medical provided a four-year loan of US$40 million to NxStage Medical as part of their strategic alliance. All outstanding principal and interest of this loan has been converted to shares of NxStage Medical, as follows.

 

[obsidianom]

I have found out that the only way to really get high blood aluminum levels is through direct membrane (dialysis membrane) to blood contact. I was also informed that GI absobtion is virtually nill so it shoudnt occur just through drinking water or aluminum containing products. It really has to be non GI. as the gut is a good filter for aluminum. Anybody with high aluminum levels has to assume it is through blood contact such as dialysis. So when the aluminum rises in a patient we are wasting our time looking for oral sources. ----Think dialysis.

[obsidianom]

http://www.compliance-alliance.com/wp-content/uploads/2010/11/Establishment-Inspection-Report-for-Rockwell-Medical-Technologies-Inc.-manufacturer-of-Dialysate-Concentrates.pdf

Everyone should go to this link to see the MAJOR violations at the Rockwell plant in SC making DIALYSATE. This is SCARY as they had numerous violations and the customer complained. The CEO is the same guy that NXSTAGE signed the contract with.
This is another smoking GUN.

[Hemodoc]

Good posts. It still is needful for NxStage to provide full disclosure of all events. That is their duty to all of their patients. We have yet to hear the full story and it should come from them. Sadly, I believe that they just want to whitewash this serious event and keep going. After all that is the manner of American Dialysis companies. It looks like NxStage is just joining the big boys in this reqard.

[slipkid]

I meet with my neph and Davita team yesterday.  My aluminum level drawn a week ago had risen from 18 micrograms per liter in January 2014 to 26 micrograms per liter. This is a 75 percent increase over January and is 189 percent above Davita's maximum permissible level for aluminum.

My water samples for tap and Pureflow water for aluminum were recorded as less than 1 part per billion.  Conclusively, the aluminum is coming from the dialysate.

My neph, who has 50 years experience in renal care, related tales of aluminum poisoning (his words) in South Africa in the 1970s.  He claimed the levels of exposure were much higher than reported in the instant case.  He ignored my complaints except for the evidence of muscle twitching. He had me walk up and down the hall and said I was fine (I was not).  I concluded he was living in the past and not up to date with current studies on aluminum exposure at the levels patients are reporting.

I asked what was Davita's position on the issue of aluminum in the dialysate.  He said he would speak to Davita's chief medical officer about it, and the use of a chelatian agent (deferoxamine) to clean me out.

He asked me WHAT I WANTED TO DO. He suggested I could go back to clinic on an every other day schedule, but I rejected that as I gained 50-60  pounds during my 7 years of clinic dialysis.  Since taking control of my dialysis 18 months ago I have lost half that weight gain.

I decided to abandon the Pureflow and use the premixed bag dialysate although I have no information on the aluminum levels in the premixed bags.

I am now ready to take action with a couple of entities that have expressed interest in the aluminum contamination crisis.

More to come at a later date.

[obsidianom]

As far as I know the premixed dialysate is made in Italy while the SAKS are from Rockwell . So you are probably ok on the premix.

[Hemodoc]

Find a renowned toxicologist at the nearest medical school. I am not sure you need chelation at this point since there are side effects of chelation, but I would seek the advice of a toxicologist.

[slipkid]

Nothing local, nearest city is Phoenix.  Also, a federally licensed, metals toxicology lab there as well.

[Speedy1wrc]

I just dumped a bunch of leaky bags today and the labels said they were made in Mexico. I am not certain the bags are any better, possibly as bad or worse. With the PAK issue I had been on bags for almost a month concluding maybe 2 weeks ago. My aluminum which was drawn on the 15th had risen to 20. I did use a known(after the fact) SAK just prior to the draw so that possibly could have been a major contributor.

On the Rockwell website they claim their manufacturing facilities are in the United States. I plan on asking them when and if they return my call.

I noted some symptoms mentioned above. I hadn't connected them to the aluminum till now but it is making more and more sense.

As far back as last year I have had the metallic taste in my mouth. I have had several surgeries for sleep apnea but still have had odd symptoms which my ENT Dr can't explain. I have difficulty swallowing and we have attributed it to a lack of saliva. My mouth dries out and my nose is always very dry. I also spend a lot of time itching my calves. So much so I have sores on my lower legs. Being Winter we assumed it was the dry air, now that it is Spring, I still have it and going back on the SAK's a couple weeks ago, it has gotten much worse. Muscle strength. For the last year I have struggled with any sort of physical activity. I am constantly off balance and I tire easily. A little over a month ago I fell and ended up with a concussion. Two weeks after that I fell face first and banged myself up pretty good. My appetite is horrid. My dietician has been baffled. I sometimes go all day without eating because I can't. When I do eat, after a few bites I feel awful. I can't remember anything. The other day my girlfriend and I went to a garage sale nearby. We took a different route there and back. My girlfriend asked why, and I told her I saw a sign for a sale on a road next to ours. We have lived there over 5 years and I am from this area. I couldn't remember the name of the road one block down from our house. I am constantly forgetting appointments. Completely forgetting, not just having them slip my mind. People are always telling me things I should know and it's as I I never heard it. The one that caught my eye above was muscle twitches. This has been something that started maybe 6 mos. ago. Insomnia notwithstanding the twitches drive me nuts. I can't even attempt to sleep without Gabapentin to make the twitches stop. The side effects are not fun though. There is so much pain on both my index fingers that there aremdays I simply can't use them. I am certainly not old enough for arthritis and the onset has been very rapid. Most days I can't get down on the floor to do any sort of work knowing that I can't get back up. My knees are in horrific pain.  It has come about within the last 6 to 9 mos. My teeth are also starting to deteriorate rapidly.. The edges are getting all pitted and wearing away. Again this has been a recent occurance with no other known cause.

I had initially thought I had only  a few symptoms but after hearing from everyone I think I have a lot more ailments related to the aluminum than I had originally believed. My girlfriend and I have been discussing the symptoms and she hasn't said anything but tonight admitted she had noticed a change in me. She has noticed me grabbing onto counters in the kitchen to steady myself or catch myself to keep from falling. Being a nerdy engineer she has noticed I haven't been as sharp as usual. I always have the answer, but more recently I stumble over my words and I struggle trying to help my daughter with her math homework. Math is my thing and I am frustrated when I get lost on simple problems.

This is much worse than I suspected. We are finding a lot of dirt and tying symptoms to the aluminum. This is getting bad.

[PrimeTimer]

My nurse just called me at work 1/2 hour ago to tell me to text her my SAKs lot numbers when I get home.  I know for sure that I'm using 401 and have to drain my Pure Flow tonight.  I'm glad this is my off night.  No wonder I felt confused most of the time, a little agitated, and some muscle rigidity.  DaVita is slacking up.... Praise God that they discover this problem.   

My husband has only been doing home hemo for 6 months using Pureflow SAKS. We don't have any of the bad SAKS but he has been feeling confused and agitated lately. He has high blood pressure so the smallest amount of stress makes it worse. Our Fresenius center called right away about the recall, so that was good but still, makes us feel a little nervous about the whole thing. His BP hasn't been too bad the past couple nites tho...we discovered the MC (Music Choice) channel on our TV and love listening to oldies but goldies, 70's rock and swing, livens up treatment sessions for us and gets our minds off all this stress. I've read a lot of your posts and think you are a strong person and have a good attitude. Hope some of that rubs off on me, too! Thanks for being an inspiration!! 

[obsidianom]

I just dumped a bunch of leaky bags today and the labels said they were made in Mexico. I am not certain the bags are any better, possibly as bad or worse. With the PAK issue I had been on bags for almost a month concluding maybe 2 weeks ago. My aluminum which was drawn on the 15th had risen to 20. I did use a known(after the fact) SAK just prior to the draw so that possibly could have been a major contributor.

On the Rockwell website they claim their manufacturing facilities are in the United States. I plan on asking them when and if they return my call.

I noted some symptoms mentioned above. I hadn't connected them to the aluminum till now but it is making more and more sense.

As far back as last year I have had the metallic taste in my mouth. I have had several surgeries for sleep apnea but still have had odd symptoms which my ENT Dr can't explain. I have difficulty swallowing and we have attributed it to a lack of saliva. My mouth dries out and my nose is always very dry. I also spend a lot of time itching my calves. So much so I have sores on my lower legs. Being Winter we assumed it was the dry air, now that it is Spring, I still have it and going back on the SAK's a couple weeks ago, it has gotten much worse. Muscle strength. For the last year I have struggled with any sort of physical activity. I am constantly off balance and I tire easily. A little over a month ago I fell and ended up with a concussion. Two weeks after that I fell face first and banged myself up pretty good. My appetite is horrid. My dietician has been baffled. I sometimes go all day without eating because I can't. When I do eat, after a few bites I feel awful. I can't remember anything. The other day my girlfriend and I went to a garage sale nearby. We took a different route there and back. My girlfriend asked why, and I told her I saw a sign for a sale on a road next to ours. We have lived there over 5 years and I am from this area. I couldn't remember the name of the road one block down from our house. I am constantly forgetting appointments. Completely forgetting, not just having them slip my mind. People are always telling me things I should know and it's as I I never heard it. The one that caught my eye above was muscle twitches. This has been something that started maybe 6 mos. ago. Insomnia notwithstanding the twitches drive me nuts. I can't even attempt to sleep without Gabapentin to make the twitches stop. The side effects are not fun though. There is so much pain on both my index fingers that there aremdays I simply can't use them. I am certainly not old enough for arthritis and the onset has been very rapid. Most days I can't get down on the floor to do any sort of work knowing that I can't get back up. My knees are in horrific pain.  It has come about within the last 6 to 9 mos. My teeth are also starting to deteriorate rapidly.. The edges are getting all pitted and wearing away. Again this has been a recent occurance with no other known cause.

I had initially thought I had only  a few symptoms but after hearing from everyone I think I have a lot more ailments related to the aluminum than I had originally believed. My girlfriend and I have been discussing the symptoms and she hasn't said anything but tonight admitted she had noticed a change in me. She has noticed me grabbing onto counters in the kitchen to steady myself or catch myself to keep from falling. Being a nerdy engineer she has noticed I haven't been as sharp as usual. I always have the answer, but more recently I stumble over my words and I struggle trying to help my daughter with her math homework. Math is my thing and I am frustrated when I get lost on simple problems.

This is much worse than I suspected. We are finding a lot of dirt and tying symptoms to the aluminum. This is getting bad.

What is your calcium level?? Some of those symptome may be from hypercalcemia which can occur from high aluminum. Also check your magnesium as that can also do it.

[Speedy1wrc]

Calcium is 9.0, magnesium isn't reported on my last set of labs.

I forgot to add....gas. It's nasty bad. Even when I am sleeping.

[obsidianom]

NXstage just changed all this .Read this abstract. Aluminum wasnt an issue until NOW

Am J Kidney Dis. 2005 Aug;46(2):316-9.

Frequency of elevated serum aluminum levels in adult dialysis patients.

Jaffe JA1, Liftman C, Glickman JD.

Abstract

BACKGROUND:

Aluminum toxicity, a complication described in dialysis patients exposed to aluminum-containing phosphate binders or water used in dialysate preparations containing elevated levels of aluminum, can cause significant morbidity. Although physicians monitor patient aluminum levels, the frequency of abnormal aluminum levels has not been reported.

METHODS:

We retrospectively examined 1,410 measurements of serum aluminum in 207 dialysis patients at the Franklin Dialysis Center (FDC; Philadelphia, PA) from January 1, 2000, through April 3, 2003. We also surveyed serum aluminum levels from a nationwide dialysis provider (DaVita) to more than 43,000 patients. Local dialysis facilities were surveyed to determine the annual frequency of aluminum testing in their patients.

RESULTS:

Of 1,410 serum aluminum measurements performed at FDC, only 30 abnormal levels (2.1%) were found. DaVita measured approximately 117,000 aluminum levels annually during the last 3 years, of which 2.5% were abnormal. Frequencies of abnormal aluminum levels declined significantly each year at FDC and DaVita.

CONCLUSION:

The current frequency of abnormal aluminum levels in our dialysis facility and a national dialysis provider is extremely low and has significantly declined.

[Speedy1wrc]

Profit then does not equal profit now.

Dialysis suppliers, providers, and clinics were used to large profit margins. Now they need to cut corners to make money. Just look at the Davita EPO scandal.

I think there are due to be big changes to the industry. Things certainly can't remain the same.

[KarenInWA]

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