FDA MedWatch - Smiths Medical Medfusion Model 4000 Syringe Infusion Pump: Class I Recall - System Errors May Cause Device Shutdown

FDA MedWatch <fda@xxxxxxxxxxxxxxxxxxxxxxx> · Fri, 03 Aug 2012 11:41:35 -0500

Title: 
    FDA MedWatch - Smiths Medical Medfusion Model 4000 Syringe Infusion Pump: Class I Recall - System Errors May Cause Device Shutdown

Smiths Medical Medfusion Model 4000 Syringe Infusion Pump: Class I Recall - System Errors May Cause Device Shutdown
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.
Read the MedWatch safety alert, including a link to the Recall Notice, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm314367.htm

You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm 

Follow MedWatch on Twitter 

Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact support@xxxxxxxxxxxxxxx. 

This service is provided to you at no charge by U.S. Food & Drug Administration (FDA). 

This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420