Developers: | Baxter International |
Branches: | Pharmaceuticals, Medicine, Healthcare |
2023: Recall of defective pumps
On November 15, 2023, the US Food and Drug Administration (FDA) announced the recall of the Baxter Novum IQ syringe infusion pumps. The use of these defective devices may result in patients receiving insufficient drug volume.
Novum IQ pumps are designed to deliver the exact amount of fluid to the patient's body in a controlled manner - whether it's nutrients or medicines. The devices are suitable for use in hospitals and outpatient medical institutions. Pumps can be used in the therapy of adults, children and newborns.
Defective Novum IQ products may reportedly indicate completion of the infusion, when this is not actually the case. The problem is due to a software error, which can lead to incorrect calculation of the volume of delivered liquid after the pump detects a blockage (occlusion). As a result, patients for whom these devices are used may receive an insufficient amount of the drug. Reduced dosage or delayed therapy can lead to serious adverse health effects - especially in people receiving life-saving medicines. It is noted that in the most severe cases this can turn into a fatal outcome.
Novum IQ pumps supplied from March 10 to August 16, 2023 are subject to recall. As of mid-November 2023, there were no reports of serious harm to health or deaths related to the problem. Baxter recommends that medical institutions monitor the operation of the pumps: if the full dose is not administered when the "Infusion is complete" signal appears, the device should be reprogrammed and the remaining volume of the drug should be injected as needed.[1]