This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.

Affected Product

The FDA is aware that Fresenius Kabi USA has issued a letter to affected health care providers recommending certain software versions of the Ivenix Infusion System be updated related to a potentially high-risk device issue:

  • Large Volume Pump (LVP) Software, version 5.9.2 and earlier
  • Product code: LVP-SW-0005
  • UDI: 00811505030122
    • This software is part of the Ivenix Infusion System and is embedded in the Ivenix Large-Volume Pump, LVP-0004 (Pump UDI: 00811505030320)

What to Do

  • On January 10, 2025, Fresenius Kabi USA began notifying affected customers recommending customers update the LVP software to version 5.10:
    • Install the new Ivenix Infusion Management System (IMS) software version (5.2) on your IMS server to facilitate the installation of the pump software, LVP SW 5.10.
    • To request installation of the software, LVP SW 5.10, contact your Fresenius Kabi representative (1-855-354-6387 or Ivenix_support@fresenius-kabi.com) to push the new software update to each of your pumps. 
      • When the software update is received by the LVP, the Update Software prompt shown below appears before the LVP is shut down.
    • Select the Update Software button to initiate the LVP version 5.10 software update. Note that the LVP will not be available for use during a software update.
      • Use care to not select the “Cancel” or “Shut Down Pump” buttons on the prompt as the software update will then not occur. The pump will prompt you every time you try to shut down the pump until the accept/install update is selected.
    • If you are unsure of the software version on your pumps, both the “Systems Dashboard” and “Pump Info” screen found under “More Options” allow you to view the Version and date for your institution.
  • If you are unable to immediately install the software, then take the following actions until the infusion pump can be updated to software version 5.10:
    • When frequent alarming occurs, restart the Ivenix LVP when clinical treatment allows.
    • Prior to starting or restarting the secondary infusion, ensure the primary infusion has some volume remaining and has not reached zero.
  • Check this web page for updates. The FDA is currently collecting information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.

Reason for Early Alert

Fresenius Kabi USA reports the following anomalies associated with software versions 5.9.2 and earlier. These anomalies have the potential to cause serious patient harm or death.

If during an alarm condition the Pause Audio option is repeated 70 times or more, it will result in the pump becoming nonfunctional, which may lead to the patient being underdosed or delay their therapy. Underdosage may lead to patient harm including temporary arrhythmias, hyperglycemia, hypo- or hypertension, undersedation, and clotting changes.

If a secondary infusion is started at the exact moment a primary infusion completes, then the pump will switch to primary once the secondary infusion completes and Volume to be Infused (VTBI) reaches 0. Then, the primary infusion will infuse at the previously programed primary rate and continue until the infusion is stopped or the bag is empty, which may lead to the patient being over infused. Over infusion may lead to patient harm including hyper- or hypoglycemia, hypo- or hypertension, electrolyte imbalance, oversedation, temporary arrhythmias, clotting changes, and unsuccessful resuscitation.

The firm has not reported any injuries or deaths associated with this issue.

Device Use

The Ivenix LVP software is the application embedded in the Ivenix Infusion System. The LVP software controls the functioning of the LVP and exchanges information with Infusion Management System (IMS) applications. When loaded with an administration set, the LVP delivers infusion therapy to an individual patient. 

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Fresenius Kabi USA at Ivenix_support@fresenius-kabi.com or 1-855-354-6387.

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.