Federal drug safety officials have announced a Class I recall for Medfusion syringe pumps, after the manufacturer identified a software defect that may allow certain devices to over or under deliver fluids and medications, posing a serious risk of serious adverse health consequences for patients.
The Medfusion Syringe Pump recall was announced after several reports of patients receiving incorrect fluid doses, including at least one serious injury.
The impacted devices are Smiths Medical Medfusion Syringe Pumps designed to deliver blood, blood products, prescribed drugs, and other fluids into a patient’s body in a controlled manner. The pumps are primarily used in the intensive care and operating room setting for neonatal, pediatric and adult populations.
An investigation into the software defect discovered the pumps may over or under deliver fluids after a specific sequence of events. According to the discoveries a medication error may occur when a bolus or loading dose is interrupted, the pump is primed, and the infusion is restarted.
Officials warn this specific sequence of functions may cause incorrect dosing delivery, increasing a patients risk of serious adverse health consequences including death.
The recall includes Medfusion Syringe Pump Model 3500-0600-00, -01, -249, -51, -82 with firmware version 6.0.0, and Model 4000-0105-249, -50, -51, -78, 4000-0106-00, -01, -231 with firmware version 1.5.0, 1.5.1, 1.6.0, 1.6.1, 1.7.0.
Approximately 46,395 recalled devices were manufactured by Smith Medical Inc. of Minneapolis, Minnesota from November 1, 2013 through June 22, 2020 and were distributed for sale to hospitals and medical facilities throughout the United States.
Smith Medical sent an Urgent Medical Device Recall notice on June 26, instructing customers to verify the firmware version of the Medfusion® 3500 and 4000 Syringe Pumps in their possession. Physicians using the impacted models are being instructed to cancel the bolus or loading dose and begin a new infusion in the event of a bolus or loading dose delivery interruption.
The FDA has classified the recall a Class I recall, meaning there is a reasonable probability that the use of the product will cause serious adverse health consequences or death.
Customers are being asked to complete and return the response form included in the medical device notice, and to ensure all personnel who utilize the pumps are aware of the recall.