The FDA determined that the recall of the Baxter
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.