FIVE KIDNEY DIALYSIS DEATHS PROMPT BAXTER/FDA ACTION

The Food and Drug Administration (FDA) today announced that Baxter Healthcare Corporation 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.

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 tubing in conjunction with Meridian dialysis machines and use other Medisystems blood tubing instead.

FDA is working closely with both Baxter Healthcare of Roundtop, Ill., and Medisystems Corporation of Seattle, to identify the exact cause of the problem.

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

Baxter's preliminary investigation found that the two hemodialysis centers where the incidents occurred may have been using the following:

Blood tubing--Medisystems Corp., Product Code D3-9694/9793 or K3-9694/9793, Baxter Product Code 5M9694

Hemodialysis Machine--Meridian

Alternate Medisystems blood tubing is available.

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

Further details can be obtained from Baxter's Postmarket Surveillance Group at 1-888-736-2543, option 3.

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