Recall Z-1381-2022 ยท PHC Infusion Safety Management Software
Ivenix, Inc.
Ivenix Infusion System (IIS)
| Date | Apr 22, 2022 |
| Status | Terminated |
| Reason | Downstream occlusion alarm is sometimes immediately followed by a pump problem alarm. |
| Root cause | Software design |
| Action | On April 22, 2022, the firm notified affected customers of the product issue through a letter titled "Important Safety Update." The firm is working on a software update to correct the issue. It will be available in approximately 60 days. The firm will inform customers when the update is ready to install. As interim corrections, the firm recommends that any pump that is infusing into the downstream access port have an infusion pressure less than 525 mm Hg. Alternatively, the Occlusion Retry Attempts in the Infusate Library Care Profile Pump Setting should be set to 0. Care profile pump settin |
| Quantity | 1335 devices |
| Distribution | US Nationwide distribution in the states of 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 |