P98-11 FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE Sharon Snider: 301-827-6242
March 27, 1998 Broadcast Media: 301-827-3434
Consumer Inquiries: 800-532-4440
FDA ISSUES WARNING ON DEFECTIVE DIALYSIS PART
The Food and Drug Administration is issuing an urgent
warning to all dialysis centers, hospitals, and dialysis patients
getting dialysis at home that an adapter for hemodialysis
catheters made or distributed by Medcomp, Harleysville, Pa., may
come apart, causing the patients on chronic hemodialysis to bleed
to death at home.
FDA has learned that three patients died and five were
seriously injured when an adapter for the catheter that connects
the patient to the dialysis machine came apart, causing severe
loss of blood. The events happened at home. The deaths occurred
when the patients were asleep. All the patients had through-the-skin
dialysis access catheters
which were permanently
The adapter in question is the Extension Adapter for a
Tesio catheter, part of a hemodialysis access kit made or
distributed by Medcomp and sold between October 1997 and February
1998 in 11 states and 9 foreign countries.
The adapter is a 2 l/2-inch piece of tubing with a fitting
at each end and a clamp in the middle. It has a red or blue
fitting which attaches to the tube that goes through the skin.
Each adapter also has a red or blue compression clamp to close
off the tube, but this clamp is only on the adapter. These Tesio
catheters are single lumen tubes, so patients will have two of
them--one with red plastic fittings and clamps and the other with
The problem extension adapters have ridged red or blue
fittings where they attach to the catheter that goes through the
skin. Similar adapters with "wings" to allow sewing to the skin
are not a problem.
FDA is urging all patients on home dialysis to contact their
dialysis center immediately to see if they have the defective
adapter. If so, they will need to have it replaced.
FDA is urging hemodialysis centers across the United States,
and particularly in 11 states (listed below) where the dialysis
accessory kits are known to have been distributed, to stop using
the defective adapters and to notify their at-home patients
about the risk.
It is not known if all Medcomp accessory kits contain the
defective adapters. However, the defective adapters can easily
be identified by hemodialysis centers. They are the adaptors
with no suture wings.
In a March 24 letter to its distributors, Medcomp announced
that it is recalling all the defective Tesio Extension Adapters
in some 27 lots.
Approximately 7,000 Medcomp accessory kits were distributed
between October and February to dialysis centers and hospitals
in the following states: California, Florida, Michigan,
Minnesota, Missouri, New Jersey, Tennessee, Texas, Utah, Virginia
They were also distributed to: Croatia, Germany, Greece,
Portugal, Saudi Arabia, Spain, Sweden, Switzerland, United