Recall Z-3153-2024 ยท FRN Pump, Infusion
Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.
| Date | Sep 26, 2024 (initiated Aug 30, 2024) |
| Status | Open, Classified |
| Reason | The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could cause serious patient harm or death. |
| Root cause | Software design |
| Action | An URGENT Medical Device Field Correction Important Safety Update notification letter dated 8/30/24 was sent to customers. Required Actions for Users: 1. Please fill out the Customer Reply Form attached to this letter to acknowledge receipt. 2. If your facility further distributes or transfers products to satellite sites or other locations, please ask these locations to contact the email address on the Customer Reply Form so we can send notice to those satellites directly. 3. Install new software version (5.9.2) for the Ivenix Large Volume Pump (LVP). See details below. How To Obtain and |
| Quantity | 17 units |
| Distribution | US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183311 | Ivenix Infusion System (IIS) Ivenix, Inc., Jun 7, 2019 |