—#188154

Product

Kaguya Automated Peritoneal Dialysis System

FDA product code: FKX — System, Peritoneal, Automatic Delivery
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K151525
Affected lot / code info: Product Code T5C8500 (distribution in Japan only)

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: BAXTER HEALTHCARE CORPORATION
Address: 25212 W Il Route 120, Round Lake, Illinois 60073-9799

Distribution

Distribution pattern: Worldwide distribution - US Nationwide distribution and the country of Japan.

Timeline

Recall initiated: 2021-06-30
Terminated: 2024-04-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #188154. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.