Medfusion 4000 Syringe Pumps recalled for software malfunction

Dec. 23, 2019

Smiths Medical ASD has recalled the Medfusion 4000 Syringe Pump with Firmware Version 1.7.0 because of an issue with the recently updated software that could potentially cause the low battery alarms to stop working. If the battery alarms do not work, a healthcare provider using a pump will not receive audible or visual notification that the battery is shutting down. This may lead to an interruption of therapy, which may lead to serious injury, adverse events or death.

This is a U.S. Food and Drug Administration (FDA) Class I recall, the most serious type of recall because use of these devices may cause serious injuries or death.

Smiths Medical ASD has received 74 complaints related to the software update. No injuries or deaths have been reported.

The Medfusion 4000 Syringe 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 the adult population.

On October 28, 2019, Smiths Medical ASD sent a Recall Notice to customers informing them of the affected models and instructing them to immediately return all affected products.

FDA has the notice.