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Author Topic:   Patient Deaths Associated with PF-5070
Gary Peterson
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posted 05-06-2002 06:13 AM     Click Here to See the Profile for Gary Peterson   Click Here to Email Gary Peterson     Edit/Delete Message   Reply w/Quote
August 28, 2002 - RenalWEB is publishing a note from Dr. Stanley Shaldon concerning a letter written by Dr. Bernard Canaud that appears in the September 2002 issue Nephrology, Dialysis and Transplantation (NDT).

The Canaud letter can be viewed on-line only by paid subscribers to NDT.

Dr. Canaud was the author of an editorial comment that appeared in Nephrology Dialysis Transplantation in April 2002 concerning the deaths last year of up to 50 dialysis patients due to exposure to perfluorocarbon (PF5070).

August 27, 2002 - Settlements have been reached with the families of two Nebraskans whose deaths at a clinic in Kearney were linked to flawed kidney dialysis filters made by Baxter International. Story from AP/Yahoo. (link is no longer available)

August 23, 2002 - Baxter International Inc. has settled with the families of hemodialysis patients in Croatia whose deaths were linked to chemical residue in a Baxter hemodialyzer. Here is an article from the Associated Press/Yahoo!. (link is no longer available)

July 18, 2002 - Baxter International Inc. has reached settlement agreements with the families of patients in the United States, Spain, and Croatia whose deaths were linked to a Baxter hemodialyzer. Here is an article from Reuters. (link is no longer available)

May 6, 2002 - RenalWEB is publishing a letter from Dr. Stanley Shaldon concerning the deaths last year of up to 50 dialysis patients due to exposure to perfluorocarbon (PF5070).

In his letter, Dr. Shaldon explains the mechanisms involved in this tragedy and suggests that the clinic staff cannot be held responsible in anyway.

Dr. Shaldon is a well-known European nephrologist, currently residing in Monaco.

March 27, 2002 - The first paper from the nephrology community has appeared on the sudden deaths of up to 50 dialysis patients last year due to exposure to perfluorohydrocarbon. The full-text of a Nephrology Dialysis Transplantation editorial comment by Bernard Canaud (on behalf of the European Experts Panel) is available on-line today.

According to the editorial, errors appear to have occurred at several levels:

  • "At the level of the dialyser manufacturer (Baxter), the removal of the fluid was apparently not adequate and quality control tests were not efficient in detecting any residual material."
  • "At the level of the regulatory notified body (TÜV), the incriminated dialysers reassessed after the first outbreak episode, were considered safe and in strict accordance with original certified dialysers."
  • "At the level of the user (dialysis unit), it is probable that the priming and cleaning procedure of the dialysers was not performed with the adequate amount of saline and/or that not sufficient time of dialysate rinsing was allowed. The severity of the clinical picture might be also the result of advanced age and comorbid conditions of certain dialysis patients."

March 6, 2002 - Baxter International Inc. reduced CEO Harry Kraemer's 2001 bonus by 60 percent due to as many as 50 hemodialysis patient deaths last year caused by a chemical-related manufacturing problem. Baxter gave Kraemer a bonus of $528,000 in 2001, down from $1.32 million in 2000. Story from Bloomberg Financial News.

The chemical pf-5070, used to test the dialyzers for leaks, failed to evaporate completely during the manufacturing process and then entered the patients' bloodstreams when the dialyzers were used for the first time. Here is the Nov. 5, 2001 press release from the Baxter web site on the discovery of this chemical in dialyzers.

November 26, 2001 - Baxter International Inc. announced today that it will close the plant in Ronneby, Sweden, that produced the hemodialyzers believed to have played a role in the deaths of more than 50 dialysis patients. Baxter also plans to stop production at a plant in Miami Lakes, Florida, that manufactured fibers for the dialyzers. Story from AP/Yahoo. (link is no longer available)

November 7, 2001 - David Griesing, a columnist for the Chicago Tribune, writes today about Baxter's management of the crisis created by the contaminated dialyzers and the resulting patient deaths. (link is no longer available)

According to the column, Harry Kraemer, Jr., Baxter's chief executive, accepted Baxter's responsibility in the incidents when he discovered two key findings. The first was that the Swedish factory early last summer had begun using a new kind of equipment to help evaporate the 3M solvent--which was used to test dialyzers, but was not intended to be introduced into patients' blood. Then, last Friday, he was told that rabbits injected with a solution containing the solvent experienced the same symptons that had led to death in human patients.

November 5, 2001 (3:17 PM) - Baxter said it was facing the worst crisis of its 80-year history after admitting today that manufacturing problems with its dialyzers could have caused the deaths of dozens of dialysis patients. Story from Financial Times (London).

Baxter said today that preliminary tests show a processing fluid (a perfluorohydrocarbon) used in its manufacturing operations in Sweden may have played a role in several recent dialysis patient deaths.

Here is the press release from the Baxter web site.

Baxter also said it is permanently ceasing manufacturing of its Series A and AF dialyzers. Baxter expects to take a fourth-quarter after-tax charge of approximately $100-$150 million to cover the cost of discontinuing this product line and other related costs.

[This message has been edited by Gary Peterson (edited 09-22-2002).]

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