Ivenix Infusion System

2024: Pump Recall

On April 17, 2024, the U.S. Food and Drug Administration (FDA) announced the recall of defective Ivenix Infusion System (IIS) infusion pumps manufactured by Fresenius Kabi. The use of these devices can lead to serious harm to the health or death of the patient.

The Ivenix system is intended for use in hospitals and outpatient settings for the controlled administration of fluids to patients: these may be drugs, blood products such as plasma, or other agents necessary to treat adults and children, including newborns and infants. Delivery of drugs can be carried out by various methods, including intravenous administration, arterial administration, epidural anesthesia and subcutaneous administration.

Ivenix

The reason for the recall is due to "numerous anomalies" in the operation of the software, which is used as part of Ivenix complexes. Because of these errors, the therapy process may be disrupted, which is fraught with severe consequences for patients. The likelihood is not excluded that failures in the operation of infusion pumps can cause deaths.

The FDA defined this as a Class I recall - the most serious type of recall. The use of these devices can lead to serious injury or death, the regulator said in a notice.

Ivenix systems with firmware version 5.8.0 are subject to recall. Such devices were delivered from March 6, 2023 to March 20, 2024. As of mid-April 2024, there were no reports of deaths related to the use of the specified equipment. As part of the recall campaign, Fresenius Kabi will install an updated software version (5.9.1) on infusion pumps, which fixes the identified problems.^[1]

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