Summary: Fresenius Kabi is recalling their Ivenix Infusion System LVP software due to serious anomalies that could harm patients, necessitating an urgent update to version 5.9.1. This Class I recall involves a direct outreach to users for software installation, with no reported injuries or deaths thus far.

Key Takeaways:

  • Urgent software update required for Ivenix Infusion System to address potential severe patient harm.
  • The FDA has categorized this as a Class I recall, indicating the highest level of risk associated with the software anomalies.

Urgent Recall of Ivenix Infusion System Software

Fresenius Kabi is recalling their Ivenix Infusion System (IIS), LVP Software, an infusion pump software. The recall will take the form of a software update.

The reason for the recall is that multiple software anomalies were occurring that have the potential to result in serious patient harm or death.

Implementation of Safety Measures

To remedy this issue, Fresenius Kabi is releasing a new software version (5.9.1) for the Ivenix Large Volume Pump (LVP).

There have been no reports of injuries or deaths associated with this issue. The FDA has designated this as a Class I recall, reflecting the severe risk the device poses to patients.

Correction and Upgrade Instructions

On March 7, 2024, Fresenius Kabi sent all affected customers an Urgent Medical Device Field Correction. The company urged customers to update all LVPs to software version 5.9.1 by reaching out to a Fresenius Kabi representative to have it installed.

The Ivenix Infusion System is used for the controlled administration of fluids to patients through various methods including intravenous line (IVs), arterial lines, epidurals, and subcutaneous delivery.