Sak Recall

[Zach]

This aluminum case reminds me of nothing so much as the granuflo case, where a change in inputs had unintended consequences.

As Bill says, shit happens.

There is a new recall for the Fresenius product NaturaLyte® Liquid Bicarbonate Concentrate:
http://finance.yahoo.com/news/voluntary-nationwide-canada-recall-naturalyte-210000427.html

 

[Speedy1wrc]

But someone did yell loud enough. My nurse has I think 9 patients now. She is an angel I will add right here and now. She has gone to bat for me with NxStage before and is not afraid to speak up. She saw two of us had elevated aluminum levels a year ago and went through the steps to figure out from where. She isolated it to the two of us using the Pureflow as opposed to the others who had normal aluminum levels using bags. She went to NxStage with that data and was shut down, being told it couldn't possibly be the SAK. We tested my tap water several times as well as the PAK. We involved the dietician to analyze everything I was eating and eliminated any environmental causes.

She now has gone back to NxStage to ask why this occurred since she did in fact bring it up to them.

With the PAK issue, and maybe not even the bad PAK's themselves, but how they handled it opened my eyes. I was on the phone with them daily and their inability to manage the problem was disturbing. Every day I would get another customer support person and inevitably I would be the one informing them that they had a problem. No one internally decided to notify the organization and develop a plan to take care of it. Literally a month into the ordeal I was still speaking to people who had no idea there was a problem. I wrote a letter to th head of their customer experience "department" and it seemed like only then did a memo go out telling everyone in customer support what to do. The fix didn't work, but at least at that point there was there was an acknowledgement that there "was" a a problem. They thought they had fixed the problem, but it still took almost another month of calls to really get them to take it seriously and then actually fix it. But then I spoke to someone trying to get some more bags sent out and that department was utterly surprised that they hadn't heard anything about the problem.

With this new issue it solidifies my feeling that there is a culture of lack of communication. I look at the cycler itself and see some brilliance in some of the design, being an engineer myself, but that was almost 10 years ago that it was designed. The technology is seriously outdated. There are numerous discussions on here of the merits of alternative therapies or methodologies that could improve overall patient outcomes. It seems as if they are sitting back and letting it ride as long as they can.

I have had a lengthy ordeal with defective equipment and all I experienced was, let's just keep throwing replacement machines out. Looking at the FDA incident reports there are over 1500 logged. Most of these are adverse events that have been logged by necessity. How many calls come in to their call center daily? Where I worked, we tracked every call and when there were too many calls coming in it triggered a response to say, what's going on? When products started being difficult to support or too costly, someone would say let's fix this. We have cartridge issues, PAK issues, SAK issues, fistula needle issues, mislabeled bagged dialysate and the only thing I see is blame being laid on external sources. It's not our fault.

I began looking at the 2008@home also. The Davita website now lists it as an option as well as the NxStage . While there are great features of the System 1, ultimately convenience is trumped by health and well being. I am waiting for how NxStage handles this current episode, but I am not waiting long before I decide to stay or leave.

[Speedy1wrc]

With the entire issue of oversized PAK's which I just had another one two days ago that didn't fit

Was it an older lot that didn't get caught or a current lot number?

[Hemodoc]

With the entire issue of oversized PAK's which I just had another one two days ago that didn't fit

Was it an older lot that didn't get caught or a current lot number?

It was probably shipped in March if I remember correctly. The PAKs I got in April fit fine. But yes, I have had mislabeled SAKs as well that said 302 when they were in a 307 sized box. They are failing at the level of post manufacturing quality assurance.

This appears to be a system wide aspect, not just you know what happens. It is above and beyond mistakes and errors. There seems to be a culture of lack of care. For medical devices, that is quite dangerous. NxStage will need step up to the plate and show some real professionalism if they are going to gain my trust back. This especially as Baxter and FMC are on the verge of entering the home hemo market. In addition, it is likely that the Quanta will seek FDA approval if something happens with NxStage market share.  They do not have good timing in "falling asleep at the wheel." This will make their solid market share quite vulnerable at a time when they should instead be taking the lead. Not a good show at all.

[caregivertech1]

My wife was undoubtedly contaminated with Sak 302 lot 3047913 and/or 3037904 which were NOT on the recall sheet. Her AL level was mid 20's in the 1st week of last July. I used these lot numbers exclusively for 6 weeks prior to the high AL test. The recall sheet showed the very first contaminated Sak we used was treatment on July 29th. Just got off the phone with Nxstage who to their credit called me back 4 days after I asked them to explain. They said if it's not on the list the product was good. There was no answer to my question "Well how do you think she was contaminated?". They were kinda surprised I had the lot numbers then I reminded them we record every lot number each treatment day.....then a silence on the other end. Still think they will eventually fess up with more recalls. Stay tuned.

[Simon Dog]

This especially as Baxter and FMC are on the verge of entering the home hemo market.

The sorbent based systems look very interesting, and could be a game changer.

[Hemodoc]

My wife was undoubtedly contaminated with Sak 302 lot 3047913 and/or 3037904 which were NOT on the recall sheet. Her AL level was mid 20's in the 1st week of last July. I used these lot numbers exclusively for 6 weeks prior to the high AL test. The recall sheet showed the very first contaminated Sak we used was treatment on July 29th. Just got off the phone with Nxstage who to their credit called me back 4 days after I asked them to explain. They said if it's not on the list the product was good. There was no answer to my question "Well how do you think she was contaminated?". They were kinda surprised I had the lot numbers then I reminded them we record every lot number each treatment day.....then a silence on the other end. Still think they will eventually fess up with more recalls. Stay tuned.

I agree, this will be a much larger incident than they are letting on to date.  It is one thing to make mistakes. It is another thing to try and whitewash them once they are uncovered. What is obvious is that they have not yet had full disclosure, nor have the confided which process was in error. We still have not heard what actually happened nor what steps that they have taken to assure nothing like this or worse happens in the future.

[Speedy1wrc]

As suggested, I highly suspect that many more lot numbers are or were involved. I am willing to bet they had a specification for aluminum and were relying on their vendor to ensure it was meeting specification. There is merit to that assumption if it is done properly. More often than not a customer will specify some requirement and the vendor will do their part and test the product to ensure compliance. Then in a duplication of effort the customer will also test the incoming product once again to check for compliance. It is possible to eliminate the incoming inspection as long as the proper safeguards are in place at the source. I think NxStage may have assumed the product met compliance which turned out to be a bad assumption.

I also believe that the lot numbers we were given were possibly the only lot numbers they could find representative samples to test. I have been having issues now for over a year and while some of the SAK's I used were on the list, many were not, yet my aluminum was still high. It seems logical that unless there were supply chain changes mid-stream or process changes, then every lot should resemble every other lot. As mentioned above there has been no disclosure as to the source of the problem nor any indication of what was or is being done to prevent it from happening in the future. We may only be seeing the tip of the iceberg.

NxStage needs to go above and beyond to win back some very cynical customers I think.

[obsidianom]

"The smoking gun has been found."    Notice the DATE.


Rockwell signs dialysate supply contract with NxStage

 March 08, 2013

 KEYWORDS nxstage / Rockwell
 
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Rockwell Medical has signed a two-year contract with NxStage Medical Inc. to manufacture dialysate concentrate for the portable home dialysis machine the NxStage System One.

 "We are pleased to enter into a supply relationship with NxStage, a leader in home hemodialysis," said Rob Chioini, Chairman, CEO and President of Rockwell.
 

[obsidianom]

"The smoking gun has been found."    Notice the DATE.


Rockwell signs dialysate supply contract with NxStage

 March 08, 2013

 KEYWORDS nxstage / Rockwell
 
Email / Print / Reprints /Notice the location .   I knew they were getting the dialysate from down in Texas and Mexico. Here is the culprit.

Rockwell Medical

4051 Freeport Pkwy # 100,
 
Grapevine, TX 76051

(972) 874-2130


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Rockwell Medical has signed a two-year contract with NxStage Medical Inc. to manufacture dialysate concentrate for the portable home dialysis machine the NxStage System One.

 "We are pleased to enter into a supply relationship with NxStage, a leader in home hemodialysis," said Rob Chioini, Chairman, CEO and President of Rockwell.

[obsidianom]

Former Rockwell Medical executive alleges SEC violations

Posted on June 20, 2012 by Chris Carey


The former head of drug development at Rockwell Medical Technologies Inc. (Nasdaq: RMTI) says the company and its chief executive knowingly issued false and misleading press releases and violated other securities laws.
 
Dr. Richard C. Yocum, who was fired from Rockwell Medical in September, alleged in a wrongful termination suit that he was ousted because he repeatedly complained to its chairman and CEO, Robert L. Chioini, about violations of Securities Exchange Commission and Food and Drug Administration rules.

[obsidianom]

Read my previous postes then this.
March 2013 Nxstage signs contract with Rockwell to manufacture dialysate. May 2013 the first contaminated batches start.
Rockwell is accused by doctor on staff of falsifying test results to FDA and SEC. 
Gee folks , you think there is a connection?
Rockwell may be behind a lot of this and Nxstage got into bed with them.

[caregivertech1]

That might also explain the Mexico connection.

[obsidianom]

It gets better:



Yocum alleged in his suit that Rockwel Medical:
 
–falsely claimed that the results of its earlier Phase IIb studies of SFP were positive, despite the fact that they failed to demonstrate that the treatment was effective.
 
– falsely claimed that the Phase IIb trials produced clear dosing data.
 
– falsely claimed that the company had an agreement with the FDA on the design of its Phase III clinical trials.
 
– proceeded with those trials despite unresolved differences with the FDA, without correcting its public statements and informing investors of those differences.
 
– announced an unrealistic date for bringing SFP to market, disregarding Yocum’s much longer timetable.
 
– failed to modify its Phase III trials to account for changes in FDA product labeling for erythropoiesis-stimulating agents, which are used to treat anemia and would likely be taken by all of the participants in the trials.

[obsidianom]

AND MORE

Yocum’s successor, Dr. Annamaria Kausz, recently left Rockwell Medical after just seven months, adding to the turnover in its clinical-development program. The company provided no explanation for that departure in the press release it issued April 19 to announce the hiring of her replacement. In fact, it didn’t even mention her or say that she had resigned.
 
Sharesleuth also noted that Rockwell Medical took the unusual step last November of extending the life of 400,000 warrants it had issued in the fall of 2008 to a consultant who was later found to have participated in a massive fraud scheme at another public company.
 
That consultant, Michael J. Xirinachs, was one of Rockwell Medical’s co-founders.

[Speedy1wrc]

Google Rockwell Medical DaVita. Apparently they also just jumped into bed with them.

[obsidianom]

AND MORE


The problems began the next month. According to Yocum’s suit, Rockwell Medical learned in February 2010 that its Phase IIb study for SFP failed to meet its primary efficacy target.
 
 “Essentially, except for showing an absence of safety issues, the study was a failure,’’ the complaint said.
 
Yocum said in the suit that he and other experts warned Chioini that the results of the study did not provide enough data on efficacy or dosing to proceed directly to Phase III clinical trials.
 
The company nevertheless issued a press release on Feb. 25, 2010 that was headlined “Rockwell Announces Positive Phase IIb Clinical Data.” The release said the study “met its objective of determining the dosing of SFP for the planned Phase III trials.’’

[obsidianom]

NEW FDA LABELING
 
Yocum said in his suit that he raised concerns in the summer of 2011 about how the Phase III trials might be affected by new dosing guidelines for a type of drug taken by people with chronic kidney disease.
 
Last June, the FDA adopted more conservative dosing guidelines for all erythropoiesis-stimulating agents (ESAs). It said dosing should be reduced or interrupted if hemoglobin levels rose to the vicinity of 11 grams per deciliter.
 
Yocum said in his suit that the randomized treatment stage of Rockwell Medical’s planned Phase III trials permitted no changes in ESA dosing until hemoglobin levels reached 12.5 grams per deciliter.
 
Yocum said that he sent an email to others at the company, summarizing the recommendations of various clinical experts and advocating a change in the trial design to incorporate the new FDA labeling.
 
Yocum said in his suit that Chioini was sharply critical of his actions, calling him “unprofessional and reckless.’’ Yocum added that Chioini stopped consulting with him before issuing press releases and other public statements about the trials.

[obsidianom]

Nxstage and Chioini CEO of Rockwell are in bed together. Real nice.

[Speedy1wrc]

So we are pretty sure we are an expendable route to profit.

[obsidianom]

Rockwell is preparing to launch its FDA approved generic drug Calcitriol, to treat secondary hyperparathyroidism in dialysis patients. Calcitriol (active vitamin D) injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It has been shown to significantly reduce elevated parathyroid hormone levels. Reduction of PTH has been shown to result in an improvement in renal osteodystrophy. Rockwell intends to launch Calcitriol once it receives FDA manufacturing approval, addressing an estimated $350M U.S. market.

WATCH OUT!!!!!

Treatment for Anemia Associated with Chronic Renal Failure
Rockwell Medical Submits NDA for Triferic

WIXOM, Mich., March 24, 2014 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (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 replacement, secondary hyperparathyroidism and hemodialysis, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of Triferic (soluble ferric pyrophosphate citrate), the Company's late-stage investigational iron-replacement drug for treating iron deficiency in chronic kidney disease patients receiving hemodialysis. The NDA submission is based primarily on the datasets derived from the Triferic Phase 3 registration study program, and includes efficacy and safety data from additional studies.

[obsidianom]

Rockwell is putting everything into this drug that the doctor who sued them claims doesnt work. They are in debt BIG time to make this work . It will screw us as dialysis patiients .




Rockwell Medical said on Tuesday that it has secured $20 million in debt financing from Hercules Technology Growth Capital. Based in Wixom, MI, Rockwell Medical is a biopharmaceutical company that targets end-stage renal disease and chronic kidney disease.
 
PRESS RELEASE
 
WIXOM, MI–(Marketwired – Jun 18, 2013) – 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 today that it closed a $20 million debt financing with Hercules Technology Growth Capital, Inc.
 “This $20 million straight-debt financing coupled with our recent $40 million equity financing provides us with sufficient cash to get SFP to commercial launch,” stated Rob Chioini, Founder, Chairman and CEO of Rockwell Medical. “We are on schedule to release Phase 3 efficacy data for CRUISE-1 and look forward to those study results.”
 Hercules Technology Growth Capital, Inc. is the leading specialty finance company focused on providing senior secured loans to venture capital-backed companies in technology-related markets, including technology, biotechnology, life science and cleantech industries at all stages of development. Since inception (December 2003), Hercules has committed more than $3.6 billion to over 230 companies.
 The CRUISE Studies
 Rockwell is conducting two pivotal Phase 3 efficacy studies called CRUISE-1 and CRUISE-2. Each study is a prospective, randomized, placebo-controlled, multicenter study to demonstrate efficacy and safety of SFP-iron, delivered via dialysate, in adult CKD patients requiring hemodialysis. Each study comprises approximately 300 patients, randomized equally between SFP and placebo groups with a treatment period of up to 12 months. The primary efficacy end-point for both studies is the mean change in hemoglobin from baseline.
 

[obsidianom]

Notice the timeline. Nxstage signed with Rockwell in March 2013 and then in APRIL 2013 WHEN THEY STARTED MANUFACTURING IT WAS CONTAMINATED.

The affected products and lots can be found in Attachment A.
The affected lots were manufactured between April 2013 and February 2014.

[Speedy1wrc]

So I decided why not...

I just called Rockwell to inquire about the recall. At first they didn't know anything about it. Then they directed me to NxStage. I told the agent they had not been forthcoming about any details so I and other patients had taken upon ourselves to find out what we could. She took my name and is referring it to quality control. She told me I should expect a call possibley Tuesday.

Failing at that approach I called NxStage's Senior Director of Customer Experience. All I got was a voicemail, so I am waiting to see what kind of response I get.

[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.