The FDA determined that the recall of the Baxter (NYSE:BAX) Novum IQ syringe pump is Class 1, the most serious kind.
Baxter designed its Novum IQ syringe pump as an infusion pump to deliver fluids into a patient’s body in a controlled manner. The device is suitable for patient care in hospitals and outpatient facilities for adults, pediatrics and neonates. The FDA cleared the Novum IQ infusion pump with Dose IQ safety software in August 2022.
Deerfield, Illinois-based Baxter recalled the pump because it may incorrectly indicate the completion of an infusion. The company traced the issue to a software error that may miscalculate volume after the pump detects an occlusion. Use of the pump could lead to serious adverse health consequences and death. It could lead to the failure to receive the amount of fluids they need or the delay of time-sensitive treatment.
Underdosing or delays can especially lead to consequences for people receiving life-sustaining medications. Baxter reports no serious injuries or death associated with the issue to date, though.
The company recalled 2,023 devices in the U.S., distributed between March 10, 2023, and Aug. 16, 2023. It initiated the recall on Sept. 21, 2023.
Baxter instructed affected customers to monitor the remaining fluid in the syringe after completing an infusion, especially when one or multiple downstream occlusions alarm. If the total dose isn’t delivered upon the “Infusion Complete” alarm, users should reprogram the pump and deliver the remaining volume as necessary.
Company representatives intend to contact affected facilities once the software upgrade becomes available.