Correction of Infusion Pump Software: Ivenix LVP Receives Updates from Fresenius Kabi

This recall pertains to modifications made to devices, and does not include their removal from usage or commerce. The FDA classifies this recall as the most critical. Continuing to use this device without correction may lead to severe injury or fatality.

Impacted Product

Illustration of the device, highlighting features such as the power button, handle, primary inlet indicator, bag hooks, cassette loading level, loading guide, air detector, cassette lock override button, touchscreen display, and battery indicators (4 LEDs). Note: Loading guides may also be termed as loading pins.

Product Names: Ivenix Infusion System (IIS) LVP Software versions 5.9.1 and earlier
Unique Device Identifier (UDI)/Product Code: 00811505030122/ LVP‐SW‐0004

Action Steps

Update software to version 5.9.2.

On August 30, 2024, Fresenius Kabi USA, LLC distributed an Urgent Medical Device Field Correction to all impacted clients, detailing the following actions:

Mandatory Actions for Users

Install the updated software version (5.9.2) for the Ivenix Large Volume Pump (LVP).
Until the new software is installed, adhere to the temporary risk mitigation procedures summarized below:

Issue Description	Temporary Risk Mitigation for Healthcare Providers Until Software 5.9.2 is Installed
Software issues may cause malfunction of pneumatic valves, resulting in pump alarms.	Supervise the Ivenix LVP pump during infusions until software version 5.9.2 is in place.
Software glitches may lead to a processor malfunction, triggering pump problem alarms.	Supervise the Ivenix LVP pump during infusions until the software update.
Might trigger a Tubing Set Problem alert, leading to alarms.	Power cycle the pump to resume therapy and minimize delay during power cycling.
If the pump struggles to obtain an IP address, it may become nonfunctional.	Power cycle the pump to continue with therapy, limiting delay to the power cycling duration.
Software issues could render the pump screen unresponsive while therapy continues.	Power cycle the pump to continue therapy, with delay limited to power cycling time.
Cybersecurity risks on the LVP could expose pump resources to threats.	Assess the environment’s impact and restrict “Can Provision Pumps” privileges “users”.

Obtaining and Installing Software Version 5.9.2

For installation requests, promptly contact a Fresenius Kabi representative at 1-855-354-6387 or via ivenix_support@fresenius-kabi.com. They will facilitate the distribution of the software update to the pumps.

After the LVP receives version 5.9.2, a notification will appear pre-shutdown:

Click the ‘Update Software’ button to begin the version 5.9.2 update. Remember, the pump will be unavailable during this update. Avoid clicking ‘Cancel’ or ‘Shut Down Pump’, or the update will not proceed. The device will prompt you every time you attempt a shutdown until the update is accepted and installed.

Consumer Actions

Complete the customer reply form attached to confirm receipt.
Instruct locations distributing products to contact the email on the reply form for direct notifications.

Reason for the Correction

Fresenius Kabi USA, LLC is rectifying issues within the Ivenix Infusion System LVP software due to various anomalies and a cybersecurity vulnerability that may delay or underdose therapies.

The use of the affected devices may lead to significant health risks like irregular heartbeat (arrhythmia), high or low blood pressure (hypotension or hypertension), inadequate sedation (undersedation), blood clotting alterations, or even fatal outcomes.

No injuries or deaths have been reported thus far.

Device Utilization

The Ivenix Infusion System is utilized in hospitals and outpatient settings for controlled fluid administration to patients via methods such as IVs, arterial lines, epidurals, or subcutaneous delivery systems. Fluids administered may encompass medications, blood products (like red cells or plasma), or other agents essential for treating both adults and pediatric populations, including neonates and infants.

Contact Information

For inquiries regarding this recall, U.S. customers should contact Fresenius Kabi USA, LLC via ivenix_support@fresenius-kabi.com or by calling 1-855-354-6387.

Additional FDA Resources

Unique Device Identifier (UDI)

The UDI is vital for tracking individual medical devices from manufacturing to patient usage in the United States, leading to improved reporting and analysis of adverse events.

Reporting Issues

Healthcare professionals and consumers are encouraged to report adverse reactions or quality concerns related to these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.