For the past couple weeks, I've been seeing search terms in my server logs referring to variations of "Alaris recall." Naturally curious, I did a few searches myself and found nothing on the web regarding any Alaris pump recalls. This morning things hit the proverbial fan with the following press release from the FDA.
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.
The press release goes on to describe an August 15 recall letter in which Alaris told 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 - which are also included in the FDA press release (linked above).
The U.S. Marshalls seized about 1,300 pumps in San Diego valued at more than $1.8 million. From a Reuters wire report:
account for less than 1 percent of revenue in the company's
Clinical Technology & Services business, which had quarterly
revenue of $649 million in fiscal fourth quarter reported on
Aug. 3, 2006.
The company said it currently is testing a modification of
the device that reduces sensitivity of the keypad. This
modification would need to be validated on the product and
approved by the FDA.
FDA said its inspections revealed that Alaris failed to
follow the agency's medical device manufacturing regulations.
No products were seized from health-care facilities or
individual users, and there are no plans to do so, the FDA
The agency said Alaris was issued warning letters in August
1998 and October 1999 outlining the violations and was given
opportunities to correct the violations, but failed to take
Note that the pumps involved are the Alaris SE (Signature Edition) pumps, and not the newer Alaris System PC pumps.
Pictured right is the Alaris Signature Edition dual channel pump.