Cardinal Health Suspends Production of Infusion Pump Following FDA Seizure

August 31, 2006
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Cardinal Health halted production, sales, repairs, and installations of its "Alaris Signature Edition Gold" infusion pump after the US Food and Drug Administration (Rockville, MD) seized approximately 1300 units last Friday. The seized infusion pumps (model numbers 7130, 7131, 7230, and 7231) have a "key bounce" defect that may cause overinfusion of medications by more than 10 times the intended infusion rate.

Dublin, OH (Aug. 28)-Cardinal Health (www.cardinal.com) halted production, sales, repairs, and installations of its “Alaris Signature Edition Gold” infusion pump after the US Food and Drug Administration (Rockville, MD, www.fda.gov) seized approximately 1300 units last Friday. The seized infusion pumps (model numbers 7130, 7131, 7230, and 7231) have a “key bounce” defect that may cause overinfusion of medications by more than 10 times the intended infusion rate. FDA’s action was intended to prevent further distribution of the infusion pumps until the defect is corrected.

On Aug. 15, Cardinal issued a recall letter to inform customers that it would distribute warning labels for the pumps. The company further announced it was attempting to correct the key-bounce problem by reducing the sensitivity of the pump’s keypad. Cardinal also gave recommendations to pump users for minimizing key-entry errors.

FDA inspections showed that Cardinal had not produced the pumps in accordance with the agency’s medical-device manufacturing regulations. The company received warning letters in August 1998 and October 1999 describing the violations. Although Cardinal had opportunities to correct the violations, it failed to take appropriate actions.

No products were seized from healthcare facilities or individual users, and pumps currently in use by customers need not be returned, according to the company.

 

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