FDA identifies Class I recall as most serious type due to software anomalies that may cause unexpected shutdowns and interface freezing.
Fresenius Kabi has issued a critical software correction for its Ivenix Large Volume Pump following identification of two anomalies that could cause serious patient harm or death, according to the Food and Drug Administration (FDA).
The FDA classified this as a Class I recall—the most serious type—affecting Ivenix Large Volume Pump Software version 5.10.1 and earlier. Healthcare facilities must update to software version 5.10.2 immediately while implementing temporary risk mitigation measures until the update is complete.
The recall affects pumps with product code LVP-SW-0005. As of Nov 18, Fresenius Kabi reported two serious injuries and no deaths associated with these software issues.
Critical Software Anomalies Identified
The two identified anomalies present significant risks to patient safety. The first involves Ivenix pumps operating on battery power for extended periods, which may inaccurately report remaining battery capacity. This can result in unexpected shutdown without the standard low-battery alarm sequence that typically provides 30-, 15-, 5-, and 1-minute warnings.
“Pumps with greater accumulated battery usage are more susceptible to this issue,” according to the FDA notice. The inaccurate battery capacity indication can lead to unexpected battery depletion, causing therapy interruption or preventing infusion initiation.
The second anomaly occurs when healthcare providers enter infusion rates with two leading zeros that exceed drug library limits. Pressing “Back” or “OK” on the Set Rate screen causes the pump to enter a fail-stop alarm state, completely freezing the interface and requiring a system reboot.
Immediate Actions Required
On Nov 14, Fresenius Kabi sent letters to all affected customers outlining specific actions required before continued use. Healthcare facilities must keep Ivenix pumps plugged in during use whenever possible until the software update is completed.
For the rate entry issue, facilities should avoid programming infusates with two leading zeros when possible. If a fail-stop alarm occurs, providers may need to reboot the pump, obtain a replacement pump for temporary use, or administer infusates by gravity during troubleshooting.
The software update requires a two-step process. Facilities must first install Ivenix Infusion Management System software version 5.2.2 on their IMS server. Once updated, individual pumps will automatically check for and prompt users to install software version 5.10.2.
Battery Health Monitoring Essential
After completing both software updates, facilities must review battery health across their pump fleet using provided monitoring tools. Pumps showing battery health of 70% or less require immediate battery replacement following manufacturer instructions.
“A battery health level of 70% or below can adversely affect performance, with further declines increasing vulnerability to functionality,” according to the FDA notice.
Healthcare providers can contact their Fresenius Kabi representative at 1-855-354-6387 or [email protected] to request the software update installation.
The Ivenix Infusion System is used in hospitals and outpatient care environments for controlled administration of fluids, pharmaceutical drugs, blood products, and other therapeutic mixtures to adult, pediatric, and neonatal patients through intravenous, intra-arterial, epidural, and subcutaneous routes.
