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FDA WARNS OF DANGER IN DIALYSIS DEVICE

The Food and Drug Administration warned kidney dialysis patients Friday that an adapter for certain dialysis catheters could break apart, putting them at risk of bleeding to death at home.

Only a small portion of kidney dialysis patients have this type of device, said Dr. Bruce Burlington, the FDA's medical device chief.

But home dialysis patients should immediately check whether they have the at-risk device -- something Burlington said is easy to tell -- so they can get a simple but vital repair.

The FDA knows of three patients who died in their sleep and another five who suffered serious bleeding when the device, made by Pennsylvania-based Medcomp Inc., suddenly broke.

The agency notified hospitals and dialysis centers Friday to check dialysis patients for the recalled device, Medcomp's Tesio Extension Adapters, that are part of a dialysis accessory kits sold between October and February.

Patients whose catheters have a knob-shaped adapter -- or who are not sure what kind they have -- should contact their dialysis center or hospital.

About 7,000 of the devices were distributed in California, Florida, Michigan, Minnesota, Missouri, New Jersey, Tennessee, Texas, Utah, Virginia and Washington.

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