Ivenix Infusion System Software Defect May Delay or Cause Incorrect Infusions
Fresenius Kabi recalls Ivenix Infusion System software versions 5.2.1 and 5.2.2 due to two defects that may delay therapy or cause over-infusion. The software fix was deployed to affected units between May and August 2023.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device software defect in infusion pump system with potential for therapy delay or over-infusion. No illnesses, injuries, or deaths reported; defects were retroactively identified and corrected in software version 5.8.0 deployed to field units in May–August 2023.
Plain-English summary
Fresenius Kabi USA, LLC is recalling software versions 5.2.1 and 5.2.2 of the Ivenix Infusion System (IIS). The system is used in healthcare settings to deliver medications and fluids through an intravenous line.
Two software defects were identified. The first defect may cause an incorrect 'Fail-Stop' alarm to activate when an administration set is loaded or coupled while the pump is starting up, which could delay delivery of therapy to patients. The second defect involves a missing alert notification when a bolus dose is entered that exceeds the maximum rate limit and the Rapid Bolus feature is selected; this could result in over-infusion.
The defects affected Ivenix Infusion Systems distributed to healthcare facilities in California, Colorado, New Jersey, Wisconsin, and Utah. Both defects were corrected in software version 5.8.0, which was installed in affected units between May and August 2023. No illnesses or injuries related to these software defects have been reported.
Healthcare facilities using this system should verify that their Ivenix Infusion System has been updated to software version 5.8.0 or later. For more information, contact Fresenius Kabi or consult the FDA recall notice.
The recalled product
- Product
- LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
- Manufacturer
- Fresenius Kabi USA, LLC
- Affected units
- 6
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 versions 5.2.1/5.2.2
Distribution
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