Pharmaceutical company Fresenius Kabi has issued an urgent recall for its Ivenix Large Volume Pump (LVP) following the identification of mechanical issues with the fluid valve pins located inside the pump’s internal housing.

The flaw is causing the pins to malfunction, striking the side of a sensor instead of moving correctly. This malfunction triggers an alarm within the system, halting ongoing infusions and rendering the pump inoperable. The issue may also be detected during the LVP setup, causing potential delays in initiating medical treatment.

The use of the affected product poses serious risks, including underdosing, therapy interruptions, or delays that could result in significant harm or even death. Despite the severity of the flaw, no injuries or deaths have been reported at this time. The U.S. Food and Drug Administration (FDA) has classified this recall as Class I, indicating it as the most serious type of recall due to the potential for severe injuries or fatalities.

On November 28, 2023, Fresenius Kabi took swift action by sending an Urgent Medical Device Recall notice to all affected customers. The notice outlined crucial steps for customers to follow, including reviewing and posting lists of affected serial numbers, sharing required actions and affected serial numbers at nursing stations, and enhancing clinical monitoring for life-sustaining medications delivered via the Ivenix LVP.

Customers were advised to use alternative pumps if the LVP displayed a Pump Problem alarm during setup, remove affected LVPs showing such alarms during use, and inform potential users about the recall letter. Fresenius Kabi committed to reaching out to customers through service representatives to develop plans for addressing affected LVPs starting in January 2024.

The Ivenix Large Volume Pump is a vital component of the Ivenix Infusion System, representing one of three primary elements. This pump utilizes air pressure to precisely control fluid flow to patients. The Ivenix Infusion System is deployed in hospitals and outpatient centers to administer fluids to patients through various routes such as IVs, arteries, the spine, or under the skin. Targeted at adults, pediatrics, and newborns, the Ivenix Large Volume Pump is compatible only with specific sterile, single-use, disposable administration sets. The recall serves as a crucial measure to safeguard patient health and well-being.