—#169659

Product

Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis.

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. All serial numbers are affected.

Why it was recalled

Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy

Root cause (FDA determination)

Software design

Action the firm took

Baxter Healthcare Corporation notified providers on about 12/11/2018 of the recall concerning the AMIA Automated Peritoneal Dialysis System, via "Urgent Medical Device Correction" letter. Patients were notified on about 1/14/2018 via "Urgent Medical Device Correction" letter. Providers were instructed to continue using the AMIA Automated PD System however, for patients who are prescribed a Cycle-Based therapy, to change these therapies to Time-Based by following the programming instructions within the Clinician Guide, Section 5.3.1 - Time-Based Programming Method. In Time-Based therapy, to maintain a fixed dwell time, the Smart Dwell treatment option needs to be Disabled. To disable the Smart Dwell treatment option, follow the programming instructions within the Clinician Guide, Section 5.3.1 - Time-Based Programming Method. Questions can be directed to Baxter's Renal Clinical Helpline at 888-736-2543, option 2, Monday through Friday, 8:00 am to 4:30 pm (CT). Providers were informed that Baxter would contact them when the software update is available and provide further instructions on how to download the upgrade remotely. They were also instructed to complete and return the Baxter Customer Reply Form and to inform customers if the device was further distributed to other facilities or departments within their institution. Patients were instructed to continue using the AMIA Automated PD System however, they were directed to check the Programming Method to ensure they have not been prescribed Cycle-Based therapy. The programming method can be verified by following section 10.3 of the Patient Guide: 1. touch "GO" on the home screen and the Confirm Treatment screen should appear, 2. touch "Program Settings" to view the program settings details and the Program Details screen will appear, 3. display the "Program Method" by navigating to Page 3 by pressing the down arrow at the bottom of the screen. If the Programming Method is Time-Based or Tidal, the iss

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: Worldwide Distribution - US Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Distributed internationally to Canada and Japan.

Timeline

Recall initiated: 2018-12-11
Terminated: 2021-02-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #169659. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.