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http://www.nytimes.com/2002/09/13/health/13KIDN.html

Warning on Equipment Is Issued After 5 Dialysis Patient Deaths

By SHERYL GAY STOLBERG

ASHINGTON, Sept. 12 — The unexplained deaths of five kidney dialysis patients — four in Indiana and one in Michigan — prompted federal regulators today to warn dialysis centers to stop using a certain combination of blood tubing and dialysis machines.

Whether the equipment is linked to the deaths is unclear. But the Food and Drug Administration issued the warning after the Baxter Healthcare Corporation, one of the country's largest makers of dialysis equipment, notified the agency that the five patients had died and that two others had been injured.

Both the agency and the Centers for Disease Control and Prevention in Atlanta are investigating.

"F.D.A. is alerting the public and the medical community to this problem in an effort to prevent other deaths and injuries," Dr. Lester M. Crawford, the agency's deputy commissioner, said. "Although details are still sketchy, in the interest of patient safety, F.D.A. wants to make certain that dialysis patients and the wider medical community are aware of these incidents."

The agency said the deaths occurred at two dialysis centers, Nephrology Inc. in Mishawaka, Ind., and Physicians Dialysis Inc. in Grand Rapids, Mich.

Bill Keegan, a spokesman for the center in Indiana, said four patients died and a fifth was hospitalized from Aug. 23 to Sept. 5, adding that it was an unusually short period. Mr. Keegan would not release details about them, except to say that their average age was over 60.

Doctors at Nephrology Inc. closed the center for five days to check and clean the equipment, Mr. Keegan said. The center also notified the disease control agency, as well as Baxter.

A preliminary investigation by Baxter found that all four patients had been treated using the company's Meridian dialysis machines in conjunction with blood tubing made by the Medisystems Corporation of Seattle. Deborah Spak, a Baxter spokeswoman, said that Baxter also received a report of a fifth death, the one in Michigan, but that it did not appear to follow the same pattern.

"Given a few of these commonalities, we felt it appropriate to ask our customers not to use these products," Ms. Spak said.

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