53 Deaths Linked to Dialysis Filters

A chemical used in the manufacture of dialyzer filters may have contributed to the deaths of 53 dialysis patients worldwide, according to preliminary tests made by the supplier, Baxter International Inc. (Deerfield, IL, USA). The deaths are being investigated by the U.S. Food and Drug Administration (FDA).

FDA investigators are reviewing 21 deaths that occurred in Croatia, 10 in Spain, seven in Taiwan, five in Germany, four in Italy, four in the United States, and 2 in Colombia. The suspected chemical, called perfluorohydrocarbon, was used in the manufacturing process of certain dialyzer fibers in Baxter's Swedish facility, although the company says it was used in the manufacture of fewer than 10% of its A and AF series dialyzers. Following the reports of the Croatia deaths, Baxter initiated a voluntary global recall of the A, AF, and AX series dialyzers and established an independent panel of dialysis experts to aid in the investigation. Confirmatory tests are now being conducted.

In the meantime, Baxter has announced that "in the interest of patient safety, the most prudent course of action is to permanently cease manufacturing these dialyzers.” The A and AF series dialyzers were part of Baxter's acquisition of Althin Medical AB (Ronneby, Sweden) in March 2000. "We are greatly saddened by the patient deaths, and I would like to extend my personal sympathies to family members of those patients,” said Harry M. Jansen Kraemer, Jr., chairman and CEO of Baxter.




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