Recall Z-0002-2023 ยท PHC Infusion Safety Management Software
Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
| Date | Oct 6, 2022 (initiated Sep 8, 2022) |
| Status | Terminated |
| Reason | The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. However, as the screen goes blank it does not indicate an alarm condition or respond. This issue leads to temporary cessation of flow of a medication or fluid, requiring immediate intervention by the clinician. |
| Root cause | Software design |
| Action | On September 8, 2022, the company notified affected customers via phone call and emailed letter. Customers were instructed to do the following: 1. If a high priority Pump Problem alarm occurs, the LVP should be powered down by holding the power button for 10 seconds then releasing the power button so that the screen goes dark, then pressing the power button again to re-start the pump. Alternatively, if you have another LVP available, you may use it to resume infusion. 2. Inform potential users of the product within your organization of this notification. If your facility further distributes |
| Quantity | 4 instances |
| Distribution | Domestic distribution to NJ and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183311 | Ivenix Infusion System (IIS) Ivenix, Inc., Jun 7, 2019 |