A Class I recall was just issued for Smiths Medical Medfusion 4000 Syringe Infusion Pump, the U.S. Food & Drug Administration (FDA) just announced. Class I recalls are the agency’s most serious recall designation and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
All Model 4000 Syringe Pumps with Software Versions V1.0 and V1.1 are involved and include Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. A complete list of the serial numbers involved can be accessed from the FDA website.
The recalled pumps were distributed from September 10, 2010 to February 3, 2012. A total of 607 pumps—257 in the United States and 350 in Canada—are in worldwide commerce.
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.
A system anomaly can cause the Medfusion 4000 infusion pump to go into an alarm condition (Watchdog Fail-Safe alarm) and stop running, and can also cause device history log corruption. When the device exhibits this failure mode, visual and audible alarms sound and the device ceases operation. This defect can result in a delay or an interruption of patient therapy. For patients who are receiving critical therapy, such as vasopressors, a delay or interruption of therapy could result in serious injury and/or death.
According to Smiths Medical ASD, there have been no reports of patient injury or death due to this problem. The firm also noted that, on February 14, 2012, Smiths Medical representatives visited consignees of Medfusion 4000 Syringe Pumps (software versions 1.0 and 1.1), who informed them that their pumps required a software upgrade. A record of this software upgrade was documented as part of the records for this action. Upgrades were completed on February 15, 2012 for United States customers. Upgrades for Canadian customers continue.
Smiths Medical ASD, Inc. is located at 1265 Grey Fox Road, Saint Paul, Minnesota, 55112-6929. Smiths Medical Customer Support can be reached, toll-free, at 1.800.258.5361, Monday through Friday, from 8:00 a.m. to 8:00 p.m., Eastern Standard Time (EST).