FDA Provides Update on Smiths Medical’s Recall of Its Medfusion Syringe Infusion Pumps

The FDA has issued an update on Smiths Medical’s April 19 recall of its 4000 and 3500 Medfusion syringe infusion pumps, deeming it a Class 1 recall because of the risk of serious injury or death.

The devices are used to deliver fluids to patients in precisely controlled amounts, including blood or blood products, lipids, drugs, antibiotics, enteral feedings and other therapeutic fluids.

The recall was prompted by the risk of eight potential software malfunctions that could cause depleted battery alarms and abnormal circuit board behavior that could lead to internal clock system failure, among other issues. The malfunctions can lead to under-infusion, over-infusion or delays in the delivery of critical medications to patients, the FDA said.

The 118,055 affected products were distributed from October 2004 to Feb. 17, 2022. One death and seven serious injuries have been reported in connection with the software issues, the agency said.