AUDIENCE: Risk Manager, Biomedical Engineering
ISSUE: FDA notified healthcare professionals and medical care organizations of the Class 1 recall of all Model 4000 pumps with software Versions V1.0 and V1.1 due to system errors that can cause the Medfusion 4000 infusion pump to go into an alarm condition and stop running, resulting in a delay or an interruption of patient therapy. Delay or interruption of infusion therapy could result in serious injury and/or death.
BACKGROUND: The Medfusion 4000 is a wireless, electronic infusion pump used to provide intravenous (IV) infusions of fluids, medications, blood, and blood products to adult, pediatric, and neonatal patients. Affected pumps were distributed from September 10, 2010, to February 3, 2012.
RECOMMENDATION: The recall was initiated February 14, 2012 and consignees of the recalled, affected product were visited by a Smiths Medical representative who informed them that their pumps required a software upgrade. These software upgrades were completed on February 15, 2012 for U.S. customers. Customers with questions about this recall may contact Smiths Medical Customer Support at 1-800-258-5361, Monday through Friday, 8:00am to 8:00pm, EST.
[08/02/2012 - Recall Notice - FDA]