|FOOD AND DRUG
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
March 27, 1998
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 implanted.
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
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 Teslo 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 and Washington.
They were also distributed to: Croatia, Germany, Greece, Portugal, Saudi Arabia, Spain,
Sweden, Switzerland, United Kingdom.