Fresenius Kabi Issues Ivenix Infusion Pump Software Update Letter: FDA

Manufacturer is advising customers to immediately update software on affected infusion pump systems to prevent severe patient injuries.

Federal health officials have issued an urgent alert to healthcare providers about the Fresenius Kabi Ivenix Infusion Pump System, following the manufacturer’s discovery of software anomalies in certain versions, which could pose serious and potentially life-threatening risks to patients.

The Ivenix Infusion System is widely used in hospitals and outpatient centers to regulate the delivery of fluids, including medications, blood products and other agents, through intravenous (IV) lines, arterial lines, epidurals and subcutaneous routes.

The system’s Large Volume Pump (LVP) software is an application embedded in the Ivenix Infusion System that controls LVP functioning and exchanges information with the Infusion Management System (IMS), which monitors and controls the delivery of medications and fluids to patients.

However, the U.S. Food and Drug Administration (FDA) announced a Fresenius Kabi Ivenix Infusion Pump Software alert on January 16, advising healthcare professionals to immediately update the LVP software to version 5.10. If the “Pause Audio” option on the pump is activated 70 times or more during an alarm condition, the pump may cease functioning, posing serious risks to patient safety.

If this malfunction occurs, patients may experience delayed therapy or underdosing, which could lead to temporary arrhythmias, hyperglycemia, hypo- or hypertension, undersedation and clotting abnormalities, which could potentially cause severe patient injuries or death.

Fresenius Kabi first alerted healthcare providers about a software issue in the Ivenix Infusion System via a letter on January 10, advising customers to install the new Ivenix IMS and LVP software versions.

If unable to immediately install the software, Fresenius Kabi advises customers to restart the Ivenix LVP when frequent alarms occur and to ensure that the primary infusion has enough volume remaining before starting or restarting the secondary infusion.

While no injuries or deaths have been reported in connection with the software malfunction, the FDA believes the devices are likely to be part of a high-risk recall.

The alert involves Ivenix Infusion System LVP software version 5.9.2 and earlier, with Unique Device Identifier (UDI) / Product Code: 00811505030122 / LVP-SW-0005.

Software versions and dates of the most recent update can be displayed on both the “Systems Dashboard” and “Pump Info” screen under “More Options.”

To obtain the new software, healthcare providers should contact a Fresenius Kabi representative at 1-855-354-6387 or via email at Ivenix_support@fresenius-kabi.com. Once the update is sent, the pump will display an Update Software prompt. The device cannot be used while updating.

Individuals with additional questions or concerns regarding the alert or products impacted are encouraged to contact Fresenius Kabi customer support at 855-354-6387 or email ivenix_support@fresenius-kabi.com.

The FDA early alert system is a pilot program that allows the FDA to quickly inform healthcare providers, manufacturers and the public of potential safety issues with medical devices, drugs or other health products.

Ivenix Infusion Pump System Concerns

Fresenius Kabi USA has issued multiple warnings and recalls related to the company’s Ivenix infusion pumps over the past year.

In September 2024, the company recalled certain Ivenix Large Volume Pumps after reports of at least two injuries linked to the device delivering an excessive amount of medication, posing a risk of overdose or death.

The following month, the company issued another recall of Ivenix Infusion System LVPs due to a separate issue where the devices delayed or reduced the delivery of medications and fluids, posing a significant risk of serious, potentially life-threatening injuries.

Most recently, in December 2024, the FDA issued an early alert for Fresenius Kabi Ivenix Infusion LVPs after discovering a defect in the pneumatic valves that may cause the devices to suddenly stop working, potentially leading to serious side effects, injuries or even death.