FDA: Medical syringe pump recalled due to software issues

A syringe pump made by a Minneapolis-based company is being recalled for risks that could cause life-threatening injuries or death.

The Food and Drug Administration (FDA) issued a Class I correction recall on Feb. 14 for the Smiths Medical Medfusion syringe pump, which is meant to administer fluids like blood, lipids, certain drugs, and more to the body.

The Medfusion Model 4000 Syringe Pump works by delivering the fluids via arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral delivery methods, according to the FDA. A Class I recall is considered the most serious as it means the product may cause serious injuries or death.

The recall was issued due to problems with the software of the medical pump, which could cause the device to fail and delay providing treatment to the user.

Smiths Medical is a medical product company based out of Minneapolis, according to a medical supply website. The company sells a variety of medical equipment.

The more than 50,000 devices in the U.S. being recalled were distributed from Nov. 16, 2010, to July 28, 2023, according to the FDA.

Those at the highest risk include healthcare providers and people in the Neonatal Intensive Care unit and Cardiac Intensive Care Unit who are treated with the pump, according to the FDA.

One person has reported injuries from the pump, although the FDA does not specify the extent of the injuries. No deaths have been reported.

Officials say some of the issues associated with the recall include:

  • Delivery During Motor Not Running High Priority Alarm
  • Re-administered Loading Dose
  • Incorrect Critical Data Failure Alarm
  • Interruption of Bolus or Loading Dose Delivery
  • Incorrect Total Bolus/Loading Dose Displayed
  • Volume Limit Before Bolus/Loading Dose Complete
  • Drug Library Lower Limit Displayed Incorrectly
  • Depleted Battery Alarm
  • Loss of Wireless Connectivity
  • PharmGuard Server Password

Customers in the U.S. with questions about this recall should contact Smiths Medical at 1-(866)-216-8806.

For more information on the recall and to report an issue, CLICK HERE.