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Deaths Prompt FDA Dialysis Warning

September 12, 2002

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WASHINGTON (AP) _ Dialysis centers are being warned not to use certain blood tubing because it may be linked with five deaths and two injuries, the Food and Drug Administration said Thursday.

The deaths occurred in late August in dialysis centers in Indiana and Michigan using certain Medisystems tubing in connection with Baxter Healthcare Corp.’s Meridian dialysis machine, the FDA said.

The FDA said it is working with Baxter, based in Roundtop, Ill., and Medisystems Corp. of Seattle to determine the cause of the problem.

Meanwhile, Baxter has notified dialysis centers to stop using the tubing in question and use other available blood tubing instead. Blood tubing that may be associated with the deaths or injuries is Medisystems product code D3-9694/9793 or K3-9694/9793, Baxter product code 5M9694, the agency said.

The FDA said the incidents occurred at Nephrology Inc. in Mishawaka, Ind., and Physicians Dialysis Inc. in Grand Rapids, Mich.

``FDA is alerting the public and the medical community to this problem in an effort to prevent other deaths and injuries,″ FDA Deputy Commissioner Lester M. Crawford said in a statement.

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Food and Drug Administration: http://www.fda.gov

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