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US Food and Drug Administration -- HHS News

FDA issues warning on defective dialysis part

FDA News Bulletin (Mar) P98:11 1998

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 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 with blue.

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 and Washington.

They were also distributed to: Croatia, Germany, Greece, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, United Kingdom.

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The FDA warning does not include details as to where these incidents occurred and exactly which form of dialysis these patients were on. The Nocturnal Hemodialysis program in Toronto (19 patients) as well as programs in US that started Nocturnal Hemodialysis following our example never had any episode of catheter blood leak. It seems the problems are related to the specific adaptor described in the report. The system of connection of the dialysis tubing to the dialysis catheter in use in Toronto is immune to separation with the use of InterLink system and a locking box.
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Andreas Pierratos, M.D. ()
Toronto, Ontario - Saturday, April 11, 1998 at 16:23:30 (PDT)

It seems that the Tesio catheter alert was not related to dialysis at night. These patients were not on dialysis when the adapter fell off, leading to bleeding.
Andreas Pierratos ()
Toronto, Ontario - Tuesday, April 14, 1998 at 20:44:34 (PDT)