Five patient deaths and two injuries may be linked to blood tubing. Baxter International Inc. has warned dialysis centers that five patient deaths and two injuries may be linked to blood tubing used with the company’s Meridian dialysis machines.
Although the cause of the deaths hasn’t been determined, Baxter notified the centers on Sept. 6 that it is exploring the possibility that the patients’ hemodialysis treatments may have used the same model dialysis machine and bloodline set or tubing, the U.S. Food and Drug Administration said on its Web site.
Deerfield-based Baxter told 16 customers across the country to immediately stop use of certain models of Medisystems Corp.’s blood tubing in conjunction with Meridian dialysis machines. The customers were instructed to use other Medisystems blood tubing instead.
Baxter spokeswoman Deborah Spak couldn’t say whether any of the customers are in Illinois.
FDA is alerting the public and the medical community
The deaths and injuries occurred in late August at Nephrology Inc. in Mishawaka, Ind., and Physicians Dialysis Inc. in Grand Rapids, Mich.
Baxter’s Meridian product has been widely used and has never generated reports of this nature in the past, said Spak, who added an investigation is in its early stages.
“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.”
The FDA said it’s working with Baxter and Medisystems of Seattle to find the cause of the problem.
Dialysis is performed on patients whose kidneys don’t properly filter or cleanse their blood. Diabetes and high blood pressure can cause kidney problems that require dialysis.
Baxter has had past problems with dialysis products
Baxter has had past problems with dialysis products. Last year it ceased manufacturing two models of filters used in dialysis after a possible link was found to more than 50 deaths mostly in Spain and Croatia. The filters were made by Sweden-based Althin Medical AB, which Baxter acquired in 2000.
Baxter acknowledged that the filters, which helped remove toxins from the blood, might have caused some of the deaths. The company reached financial settlements with families of all the victims, Spak said.
It’s too soon to say how this latest development will affect the company, said analyst Jordan Schreiber. He manages about $1 billion for the Merrill Lynch Health Fund, which doesn’t now hold Baxter shares.
”A lot depends on the age of the people who died, how sick they were and to what the FDA is attributing these unfortunate events,” he said.