FDA Sends Marshals To Seize Medical Equipment

At the request of the U.S. Food and Drug Administration (FDA), the U.S. District Court for the Southern District of California issued a warrant for seizure of Alaris Signature Edition Gold infusion pumps, model numbers 7130, 7131, 7230 and 7231. The pumps are manufactured by Cardinal Health Care 303, Inc. and the seizure occurred August 25. The seized infusion pumps have a design defect called "key bounce" that may cause potential over-infusion of medications. This seizure was intended to ensure that infusion pumps located at Alaris' manufacturing facility are not distributed unless the problem is corrected.

Infusion pumps are electronic devices intended for controlled delivery of intravenous solutions and medications to patients. Key bounce occurs when a number pressed on the pump registers twice although the operator only pressed the key once. If a key bounce occurs and is not detected during programming verification, it may result in an infusion rate at least 10 times the intended infusion rate. For example, if an infusion rate is intended to be entered as 4.8 milliliters per hour and the key bounce occurs when the 4 is pressed, the actual rate registered will be 44.8 milliliters per hour. If not detected during programming verification, key bounce events may result in serious patient harm or death.

FDA inspections revealed that Alaris failed to follow FDA's medical device manufacturing regulations. The infusion pumps were seized by the U.S. Marshals Service at Alaris' manufacturing facility in San Diego, California. The seized devices valued at more than an estimated 1.8 million dollars. Alaris has distributed these products nationally and internationally. No products were seized from healthcare facilities or individual users, and there are no plans to do so.

Alaris was issued warning letters by FDA in August 1998 and October 1999 outlining the violations and was given opportunities to correct the violations, but failed to take appropriate actions.

In an August 15 recall letter, Alaris informed customers that it will provide a warning label for the pumps and a permanent correction for the key bounce problem once it is available. In the letter, Alaris also provided recommendations to pump users on steps they can take to minimize key entry errors until the problem can be corrected.

posted by Consumer Help Web Editorial Team at 12:43 PM |