Recall Z-2174-2021 ยท FKX System, Peritoneal, Automatic Delivery
BAXTER HEALTHCARE CORPORATION
Kaguya Automated Peritoneal Dialysis System
| Date | Jun 30, 2021 |
| Status | Terminated |
| Reason | Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes the function of the UF (Ultrafiltration) Limit setting as the ending criteria of the cyclers Extra Last Drain Mode. In some locations in the guide, it states that the UF volume achieved must exceed the programmed UF Limit before the cycler will end the Extra Last Drain, allowing the patient to end therapy or proceed to their last fill. |
| Root cause | Under Investigation by firm |
| Action | The firm notified its consignees by letter on 06/30/2021. The letter explained the issue with the instructions for use, specifically, That the AMIA Sharesource User Guide describes the function of the UF (ultrafiltration) Limit setting as the ending criteria of the cycler's Extra Last Drain Mode. Baxter will be sending a Follow-Up communication once the AMIA Sharesource User Guide has been updated on the portal. |
| Quantity | 5101 units |
| Distribution | Worldwide distribution - US Nationwide distribution and the country of Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151525 | Amia Automated PD System with Sharesource Deka Research and Development, Oct 9, 2015 |