Important Notification: Fresenius Kabi USA’s Infusion Pump Concerns

This announcement is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has identified a potentially significant device issue and will provide updates on this web page as new information becomes available.

Affected Product

The FDA has noted that Fresenius Kabi USA has communicated to health care providers regarding the need to remove specific Ivenix large-volume pumps for necessary repairs.

• Ivenix large-volume pump, LVP-0004
• UDI 00811505030320

What to Do

• On December 5, 2024, Fresenius Kabi USA advised all affected customers to perform the following actions until the affected LVPs are returned for pneumatic valve repair:
  • Examine the list of affected Serial Numbers and post the list prominently. Isolate all affected devices to prevent unintended use if possible.
  • If removing the devices is impractical due to the lack of alternatives, proceed cautiously as outlined below:
    • If the Ivenix LVP is used to administer life-sustaining drugs, enhance clinical supervision, and ensure a backup LVP is at hand. If issues arise, remove the pump and utilize the backup while reporting the event to Fresenius Kabi.
    • For a Pump Problem alarm during setup, switch to a different LVP and alert your biomedical engineers. Remove the pump and inform Fresenius Kabi.
    • If a Pump Problem alarm occurs during use, reprogram another LVP for the infusion, notify biomedical engineers, and remove the pump while reporting to Fresenius Kabi.
    • Display the instructions and the list of affected Serial Numbers at each nursing station.
  • Notify potential users within your organization of this alert.
  • Monitor this page for updates. The FDA is gathering information concerning this device issue and will keep the public informed with significant updates.

Reason for Early Alert

Fresenius Kabi USA has indicated that a certain group of pneumatic valves in some Ivenix LVPs are more likely to trigger a non-recoverable pump problem alarm. All devices identified with these valves are to be withdrawn from use as specified above for evaluation and repair.

• If a pneumatic valve malfunctions, a Pump Problem alarm will be activated.
• If this occurs during setup, it could potentially delay therapy.

• If this failure arises during an active infusion and interrupts flow, it may lead to an underdose.

• Delays or interruptions of life-essential infusions can result in severe consequences, including permanent disability or death.

The pump problem alarms serve their intended purpose by signaling when action is needed if a malfunction occurs. There have been no reported injuries or fatalities related to this issue.

Device Use

The Ivenix LVP is a large-volume infusion pump intended for administering fluids and medications from one or two source containers to a patient through a single exit point. When paired with an administration set, the LVP provides infusion therapy to an individual.

Contact Information

U.S. customers facing adverse effects, quality concerns, or inquiries regarding this recall should reach out to Fresenius Kabi USA at Ivenix_support@fresenius-kabi.com or call 1-855-354-6387.

Unique Device Identifier (UDI)

The unique device identifier (UDI) serves to identify individual medical devices marketed in the United States, enabling efficient tracking from distribution to utilization. This system enhances the accuracy of reporting and analysis of adverse incidents, allowing for quicker identification of issues and more timely resolutions.

How do I report a problem?

Health care professionals and consumers can report adverse reactions or quality problems experienced with these devices through MedWatch: The FDA Safety Information and Adverse Event Reporting Program.