Fresenius Kabi USA, LLC Recalls Ivenix Large Volume Pump (LVP) of the Ivenix Infusion System Due to Mechanical Interference
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product
- Product Names: Ivenix Large Volume Pump
- Product Codes: FRN
- Model Numbers: LVP-0004
- Distribution Dates: October 1, 2021 to July 31, 2023
- Devices Recalled in the U.S.: 938
- Date Initiated by Firm: November 29, 2023
Device Use
The Ivenix Large Volume Pump (LVP) is one of three primary components of the Ivenix Infusion System. It's a pump that uses air pressure to precisely control the flow of fluids to the patient.
The Ivenix Infusion System is used in hospitals and outpatient centers to carefully give fluids to patients, through different routes like IVs, in arteries, in the spine, or under the skin. It is intended for adults, pediatrics, and newborn babies.
The Ivenix Large Volume Pump is compatible only with specific sterile, single-use, disposable administration sets, including:
- Primary dual inlet, single outlet, 1 Y-site
- Primary single inlet, single outlet
- Blood Set, dual inlet, single outlet, 1 Y-site, for administration of red blood cells, platelets and plasma
- Microbore single inlet, single outlet, for administration of epidural fluids
- Microbore dual inlet, single outlet, 1 Y-site
- Primary dual inlet, single outlet, dual Y-site
- Microbore dual inlet, single outlet, dual Y-site
- Microbore single inlet, single outlet
Reason for Recall
Fresenius Kabi is recalling the Ivenix Large Volume Pump (LVP) because some units have mechanical issues with the Fluid Valve Pins, located inside the pump's internal housing, causing the pins to not move properly. Instead of going where they should, they impact the side of a sensor. When this happens, the system detects the failure and sets off an alarm, stopping the infusion if it is in progress and preventing the pump from working. The failure may also be detected during the LVP setup, causing a delay in starting treatment.
The use of affected product could lead to underdose, interruption in therapy, or delay of therapy, which could lead to serious harm or death.
There have been no reports of injuries or death.
Who May be Affected
- People who are treated in a health-care setting using the Ivenix Infusion System.
- Health care personnel who use Ivenix Infusion Systems to deliver blood and medications to patients in health care settings.
What to Do
On November 28, 2023, Fresenius Kabi sent all affected customers an URGENT Medical Device Recall notice.
The letter requested customers to:
- Review and/or post the list of affected serial numbers.
- Consider posting the required actions and affected serial numbers at each nursing station.
- Increase clinical monitoring if life-sustaining medications are being delivered using an Ivenix LVP.
- Use a different pump if the LVP exhibits a Pump Problem alarm during set up.
- Remove affected LVPs that exhibit a Pump Problem alarm during use.
- Inform potential users of the affected LVPs of the recall letter and complete and return the Customer Reply Form attached to the letter.
Customers will be contacted by a Fresenius Kabi service representative to create a plan for addressing any affected LVPs beginning in January 2024.
Contact Information
Customers in the U.S. with questions about this recall should contact Fresenius Kabi customer support at 1-978-775-8100.
Additional Resources:
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 using an online form, regular mail, or FAX.