September 13, 2001
FIVE KIDNEY DIALYSIS DEATHS PROMPT
- 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
FDA is working closely with both Baxter Healthcare of Roundtop, Ill., and
Medisystems Corporation of Seattle, to identify the exact cause of the
"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
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.