Recall Z-1283-2024 ยท FRN Pump, Infusion
Fresenius Kabi USA, LLC
LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
| Date | Mar 11, 2024 (initiated May 10, 2023) |
| Status | Completed |
| Reason | 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. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 6 US |
| Distribution | US Nationwide distribution to the states of CA, CO, NJ, WI, UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183311 | Ivenix Infusion System (IIS) Ivenix, Inc., Jun 7, 2019 |