Smiths Recalls Medfusion 4000 Syringe Pumps

Smiths Medical ASD has recalled its Medfusion 4000 Syringe Pumps due to malfunctioning alarms and potential therapy interruption. The company has become aware of a software issue in the most recently updated device firmware, version 1.7.0, that could potentially cause the low battery alarms to stop working, a recall notice says. “If the battery alarms do not work, the healthcare provider using the pump will not receive audible or visual notification that the battery is shutting down,” it says. The issue may lead to an interruption of therapy which could cause serious injury, adverse events, or death. Smiths Medical says it has received 74 complaints related to the software update, and no injuries or deaths have been reported.

The pump is used to deliver blood, blood products or prescribed drugs into a patient’s body in a controlled manner. Syringe pumps are primarily used in the neonatal and pediatric populations and in operating rooms and intensive care units for adults.