Class 2 Device Recall AMIA Automated Peritoneal Dialysis Cycler

• Date Initiated by Firm: December 11, 2018
• Create Date: February 20, 2019
• Recall Status: Terminated on February 12, 2021
• Recall Number: Z-0849-2019
• Recall Event ID: 81738
• 510(K)Number: K151525
• Product Classification: System, peritoneal, automatic delivery - Product Code FKX
• Product: AMIA 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.
• Code Information: Product code 5C9320. All serial numbers are affected for devices distributed from 02/11/2016 through 11/27/2018.
• Recalling Firm/ Manufacturer: Baxter Healthcare Corporation; 1 Baxter Pkwy; Deerfield IL 60015-4625
• For Additional Information Contact: 888-736-2543
• Manufacturer Reason for Recall: Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy
• FDA Determined Cause: Software design
• Action: 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
• Quantity in Commerce: 7,688 devices
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FKX