Ivenix Infusion System Software Startup Delays in Certain Flow Rate Ranges
Fresenius Kabi USA has recalled Ivenix Infusion System Large Volume Pump software versions 5.0.0 and 5.0.1 due to startup time delays that may exceed 6 minutes at flow rates between 50-200 ml/hr.
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 used for medication delivery qualifies as a risk-of-harm product. The startup delay exceeding the 6-minute specification could impact timely medication administration. No adverse events have been reported, placing this at the high end of non-critical recalls.
Plain-English summary
Fresenius Kabi USA, LLC is recalling the Ivenix Infusion System (IIS) Large Volume Pump (LVP) software versions 5.0.0 and 5.0.1 (Part Number LVP-SW-0004). This medical device is used in hospital and outpatient care settings for controlled administration of fluids. Approximately 1,344 units have been distributed nationwide.
The recalled software versions have a startup timing issue in certain flow rate ranges. For flow rates greater than 50 ml/hr and less than 200 ml/hr, the startup time may exceed the specified 6 minutes. This timing issue depends on characteristics of air bubble entrapment within the Intermediate Pumping Chamber (IPC) of the administration set.
Facilities using affected pumps should verify the software version and contact Fresenius Kabi USA for information about available corrective actions or software updates.
The recalled product
- Product
- Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. 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
- Affected units
- 1,344
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): 00811505030122 Software Version: 5.0.0 and 5.0.1
Distribution
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