FDA designates Class 1 recalls for infusion pump software, ventilator software

Editor's Note

The US Food and Drug Administration (FDA) designated software-related recalls for Fresenius Kabi USA’s Iveni Infusion Systems and Philips Respironics Triology Evo ventilators as class 1, the most severe category indicating serious risk of injury or death.

According to FDA’s October 1 announcement, Fresenius recalled the Ivenix Infusion System Large Volume Pump (LVP) software due to multiple anomalies and a cybersecurity vulnerability. These issues could result in delay or dosage errors, with potential consequences including arrhythmia, hyperglycemia, hypotension or hypertension, undersedation, blood clotting changes, and death. No deaths or injuries have been reported.

The full announcement offers a table of recommendations for users to follow until they can update the software to the latest version.

According to a separate October 1 FDA announcement, Philips Respironics is updating software to correct several previously reported and new safety issues that could affect the breathing of patients using the Trilogy Evo, Trilogy EV300, Trilogy Evo O2, and Trilogy Evo Universal ventilators. Potential issues include inaccurate displays and inadequate oxygen supplies; false power loss that stops therapy; alarm errors; and more. Potential adverse consequences for patients include hypoventilation, hypoxia, and death, FDA reports. Nine injuries and one death have been reported.

Devices should not be used until the software is successfully updated. Users should also be aware of addendums to user manuals, including required use of Philips-approved particulate filter to prevent environmental contamination. See the full announcement for additional detail.