Smiths Medical Syringe Pump Recall is Class 1

FDA has classified as Class 1 a recall of Smiths Medical Medfusion Syringe Pumps (Models 3500 and 4500) due to the risk of medication delivery errors related to a software error. The devices are intended to deliver blood, blood products, prescribed drugs, and other fluids into a patient’s body in a controlled manner. Syringe pumps are primarily used in neonatal and pediatric populations or in operating rooms and intensive care units for the adult population, a recall notice says.

Smiths Medical says the software error may lead to over-delivery or under-delivery of fluids or medications. “Over- or under-delivery can occur if the following specific sequence of events occur: a bolus or loading dose is interrupted, the pump is primed, and the infusion is restarted,” the recall notice says. “Use of the affected syringe pumps may cause serious adverse health consequences including death.” There have been four complaints about the device issue, including one serious injury.