Why did FDA request a seizure of the Alaris Signature Edition infusion pump?
Alaris has violated FDA’s quality system regulations several times. A February 2006 inspection found significant manufacturing and quality violations for this product line. After FDA laboratories confirmed the key bounce problem, FDA requested the seizure of all violative products at the firm’s facility. This seizure was limited to the pumps that were at the site and did not affect the distribution of any units that were confirmed not to have the key bounce problem. Are these pumps safe to use? FDA believes that the Alaris Signature Edition infusion pumps can be used safely by following the company’s instructions. Alaris has provided the following instructions: • 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 dou
