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November 12, 2001
Volume 79, Number 46
CENEAR 79 46 p. 6
ISSN 0009-2347
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Perfluorocarbon fluid used to test dialyzer fibers is the apparent culprit


Baxter International says preliminary tests indicate that a fluid used in the production of some of its kidney dialyzers "is the likely cause" of 51 deaths, mostly in Spain and Croatia.

The Deerfield, Ill.-based company says it appears that the dialysis units were contaminated by a perfluorohydrocarbon processing fluid used to test for leaks in some dialyzer fibers during the production process. The process is used only in Baxter's plant in Ronneby, Sweden, and in production of less than 10% of the three models of dialyzers associated with the patient deaths.

The specific fluorinated fluid, known as 5070, is produced by 3M for a variety of industrial and commercial applications. It is described in 3M's material safety data sheet as a fluid containing "perfluoro compounds--primarily compounds with seven carbons."

The problem first surfaced with the deaths of 11 dialysis patients in Spain in August, prompting the company to put a worldwide hold on the specific series of dialyzer being used. At the time, the company also had the units checked by TÜV PS, an independent European consulting firm specializing in medical-device safety, which could find no problems with them.

However, Baxter received a further jolt when 21 patients died in one week in October in Croatia. The company immediately launched a global recall of the three models and began tests to track down the problem. Subsequent deaths in Spain, Croatia, Taiwan, and Colombia, as well as Texas and Nebraska in the U.S., have brought the number of fatalities to 51.

Baxter has earmarked $100 million to $150 million in fourth-quarter after-tax charges to cover costs of discontinuing the product series and other related costs, including litigation. Legal action is being weighed by patients' groups and governments in Spain, where the company is facing a lawsuit involving the deaths of 10 dialysis patients in Madrid and Valencia, and possibly in Croatia.

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