September 5, 2006

FDA ALERT

Subject: FDA MedWatch - Alaris SE Infusion Pumps recalled due to risk of overinfusion at ten times intended infusion rate

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA and Alaris Products notified healthcare professionals of a recall of defective infusion pumps due to a design defect called "key bounce" that may cause potential over-infusion of medications and result in an infusion rate at least 10 times the intended infusion rate. Infusion pumps are electronic devices intended for controlled delivery of intravenous solutions and medications to patients. Key bounce occurs when a number pressed once on the pump registers twice and not detected during programming verification. The products included in this recall (model numbers 7130,7131, 7230, and 7231) are distributed by Cardinal Health Care 303 Inc. The manufacturer provided recommendations to pump users on steps they can take to minimize key entry errors until the problem can be corrected. Healthcare facilities can continue to use pumps in their possession, guided by the company's instructions.

Read the complete MedWatch 2006 Safety Summary, including links to the FDA press statement and firm recall notice, at:
http://www.fda.gov/medwatch/safety/2006/safety06.htm#Alaris

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