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Medical Devices

Smiths Medical Medfusion Model 4000 Syringe Infusion Pump

Recall Class: Class I

Date Recall Initiated: February 14, 2012

Product: Smiths Medical Medfusion 4000 Syringe Infusion Pump

Model Numbers: All Model 4000 Syringe Pumps with Software Versions V1.0 and V1.1

Reorder Numbers: 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78

Serial numbers are available on the FDA’s website

Distribution Dates: Affected pumps were distributed from September 10, 2010, to February 3, 2012.

Intended Use: 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.

Recalling Firm:
Smiths Medical ASD, Inc.
1265 Grey Fox Road
Saint Paul, Minnesota 55112-6929

Reason for Recall: 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.

Public Contact: 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.

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.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

Page Last Updated: 01/12/2015
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