| Developers: | Baxter International |
| Branches: | Pharmaceuticals, Medicine, Healthcare |
Content |
2025: Marriage in Devices - They Serve Too Little and Much Medicine in the Body
In mid-June 2025 USA FDA , the Food and Drug Administration announced the recall of infusion pumps. Their Baxter use can cause serious harm to the health of patients and even provoke death.
We are talking about devices of large volume Novum IQ. They are used for the controlled delivery of the exact amount of fluid into the patient's body - for example, drugs or nutrients. Pumps can be used in the therapy of adults and children.
The identified problem is due to the fact that Novum IQ devices under certain conditions can supply too little and many drugs to the body. The defect, in particular, manifests itself after the use of the "standby mode" function and in some other cases. Baxter states that defective pumps can show variability in the flow rate of the injected fluid. This variability can exceed 10% in two hours and 30 minutes. In such a situation, pediatric patients may face the risk of dehydration or inadequate drug therapy. In addition, insufficient blood infusion may be observed. As a result, the likelihood of serious health problems and death increases.
The issue affects Novum IQ LVP infusion pumps with all serial numbers. As of April 2025, one serious injury to a patient due to the use of a defective device is known. At the same time, deaths were not registered.
Baxter has instructed medical facilities not to exceed the programmed wait time of two hours and 30 minutes. They should also monitor regularly the process of injecting fluid into patients' bodies.[1]
2023: Recall of defective pumps that cause patients to receive insufficient medication
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.[2]
Notes
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