FDA Has Alaris SE Infusion Pumps Seized
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 at the FDA’s request. The seizure of about 1,300 units valued at $1.8M overall was executed by U.S. Marshals at Alaris’ manufacturing facility in San Diego, California on August 25 because of a “key bounce” design defect that may cause over-infusion of medications. Cardinal Health announced (pdf) it suspended production, sales, repairs and installations. On August 15 a field corrective action had been initiated by the manufacturer which is also testing a reduction of the keypad’s sensitivity. About 140,000 Alaris SE pumps have been distributed worldwide in 12 years. There is no product recall at this point. The FDA is accusing Cardinal of not respecting medical device manufacturing regulations even though it had issued warning letters as early as August 1998 and October 1999 outlining violations.
The letter (pdf) sent by Cardinal Health to customers on August 15 recommended the following:
Proper Stance
When programming pumps, stand squarely in front of the keypad (ideally with the pump at eye level for best visibility) to facilitate proper depth of depressing each key.
Listen
Focus on listening to the number of beeps while programming IV pumps; each beep will correspond to a single digit entry. Unexpected double tone could indicate an unintended entry.
Verify Screen Display
When programming the pump or changing settings, always compare the patient’s prescribed therapy or the medication administration record, original order, or bar code device to the displayed pump settings for verification before starting or re-starting the infusion.
Independent Double Check
Request an independent double check of pump settings by another practitioner before starting or changing infusions with hospital-selected high alert drugs.
Look
Before leaving the patient’s room, observe the IV tubing drip chamber to see if the observed rate of infusion looks faster or slower than expected. Adjust accordingly.
Healthcare facilities can continue to use pumps in their possession, guided by these and further instructions.
August 28, 2006 Related topics: Product Recalls, Medical Devices & Products