Ivenix Infusion System software recalled for pump malfunction risk
The FDA recalled Ivenix Infusion System software versions 5.9.2 and earlier for potential device malfunctions that could affect medication delivery. Two known anomalies may cause pump failure or improper infusion rates.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall is classified as FDA Class I, which per FDA regulations indicates potential for serious patient harm. The identified software defects could result in device malfunction or improper medication delivery. Although no patient injuries have been reported, the Class I classification and critical nature of infusion systems in healthcare necessitate this severity level.
Plain-English summary
The Ivenix Infusion System (IIS) Large Volume Pump (LVP) software, versions 5.9.2 and earlier, is being recalled by the FDA. The system is used in hospitals and outpatient care settings to deliver fluids and medications. A total of 23 systems have been distributed across multiple US states including California, Colorado, Georgia, Idaho, Michigan, Mississippi, Nebraska, New Jersey, Nevada, Oklahoma, Texas, Utah, Virginia, Washington, and Wisconsin.
Two software anomalies have been identified. First, if the Pause Audio alarm option is repeated 70 or more times during an alarm condition, the pump may become nonfunctional. Second, if a secondary infusion is started at the exact moment a primary infusion completes and the VTBI (volume to be infused) reaches zero, the system will incorrectly switch to the primary infusion and continue delivering at the previously programmed primary rate until the infusion is manually stopped or the bag is empty.
Healthcare facilities using this system should contact the manufacturer, Fresenius Kabi USA, LLC, to obtain updated software versions that address these issues. Patients and providers should be aware of these potential device malfunctions when managing infusion therapy.
The recalled product
- Product
- Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Medical Device — Infusion Pump
- Hazard
- pump-malfunction
- software-defect
- infusion-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 00811505030122. Software 5.9.2 and prior
Distribution
Distributed in 15 states:
- CA
- CO
- GA
- ID
- MI
- MS
- NE
- NJ
- NV
- OK
- TX
- UT
- VA
- WA
- WI
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