Regulatory Issues

Five kidney dialysis deaths prompt Baxter/FDA action

Published in Medical Letter on the CDC and FDA, October 13th, 2002

The U.S. Food and Drug Administration (FDA) has announced that Baxter Healthcare Corp. has notified dialysis centers that certain blood tubing used with Baxter's Meridian dialysis machines may possibly be linked to five patient deaths and two injuries. These occurred at two kidney dialysis centers in late August 2002.

Although the cause of the deaths has not yet been determined, Baxter on September 6 notified hemodialysis centers that it is exploring the possibility that the patients' hemodialysis treatments may have used the same model dialysis machine and bloodline set. Baxter told customers to immediately discontinue use of certain models of Medisystems blood...

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Source: Medical Letter on the CDC and FDA (2002-10-13)

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