Company: Smiths Medical ASD, Inc.
Date of Enforcement Report 8/2/12
Date Recall Initiated: February 14, 2012
Class l:
PRODUCT
Smiths Medical Medfusion 4000 Syringe Infusion Pump.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.Z-2107-2012
Distribution Dates: Affected pumps were distributed from September 10, 2010, to February 3, 2012.
REASON
System errors can cause the Medfusion 4000 infusion pump to go into an alarm condition and stop running, which can result in a delay or an interruption of patient therapy. For patients receiving critical therapy, such as vasopressors, a delay or interruption of therapy could result in serious injury and/or death. According to the firm, there have been no reports of patient injury or death due to this problem.
RECALLING FIRM/MANUFACTURER
Smiths Medical ASD, Inc., Saint Paul, Minnesota
VOLUME OF PRODUCT IN COMMERCE
607 pumps
DISTRIBUTION
Nationwide and Internationally
FDA District: Minneapolis
FDA Comments:
On February 14, 2012, consignees of Medfusion 4000 Syringe Pumps with software versions 1.0 and 1.1 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. Upgrades for Canadian customers are ongoing.
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