Smiths Medical Medfusion Model 4000 Syringe Infusion Pump Recalled due to System Errors that can cause Device Shutdown

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The US FDA notifies Risk Manager and Biomedical Engineering healthcare personnel that Smiths Medical Medfusion Model 4000 Syringe Infusion Pump is recalled because, due to the potential for system errors, the possibility of device shutdown may cause life-threatening injuries.

Background of Smiths Medical Medfusion Model 4000 Syringe Infusion Pump

Medfusion 4000 Syringe Infusion Pump, by Smiths Medical ASD Inc., is an electronic and wireless infusion pump used for the intravenous infusion of fluids, blood and medication to patients ranging from neonatal to adults. FDA Alert on Smiths Medical Medfusion Model 4000 Syringe Infusion Pump

FDA’s reason for the recall is that system errors may cause the product to stop running, leading to possible interruption of patient’s therapy. This may lead to serious injury, including death.

The affected model numbers are all Model 4000 Syringe Pumps with Software Versions V1.0 and V1.1.

The affected reorder numbers are: 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78.

The FDA classified this recall as Class I, meaning use of the products included in the recall may cause serious injuries or death.

Recommendation on Smiths Medical Medfusion Model 4000 Syringe Infusion Pump

 “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.”

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