LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
FDA device recall Z-1283-2024 · posted 2024-03-11 · Completed
Recall details
- Recalling firm
- Fresenius Kabi USA, LLC
- Reason for recall
- Retroactively reported corrections from 2023: 1) A software defect may cause an incorrect (Fail-Stop) alarm when an administration set is loaded or coupled while the pump is executing the power-up sequence. May lead to delay in therapy. 2) Alert is not annunciated informing the clinician that the bolus cannot be delivered when the entered bolus dose exceeds the Care Profile Hard Rate Max limit and Rapid Bolus is selected. May lead to over infusion. Both issues were resolved in all fielded product in software version 5.8.0, which was installed in affected units May thru August 2023.
- Action taken
- Both issues were resolved through an update of the software to Version 5.8.0, which was installed at customer sites between May and August 2023. The firm did not issue a customer letter at the time. According to the firm, this issue has been resolved in all fielded product.
- Root cause
- Software design
- Status
- Completed
- Product code
- FRN
- Quantity affected
- 6 US
- Distribution
- US Nationwide distribution to the states of CA, CO, NJ, WI, UT.
- Date initiated
- 2023-05-10
- Date posted
- 2024-03-11
- Location
- North Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Ivenix Infusion System (IIS) (K183311) | Ivenix, Inc. | 2019-06-07 |