Baxter Healthcare Corporation: 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.

Recall number

Z-0850-2019

Recalling firm

Baxter Healthcare Corporation

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.

Status

Terminated

Initiated

2018-12-11

Posted

not on file

Terminated

2021-02-12

Reason

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

Root 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

1,085 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.

Lot, serial or model codes

Product code T5C8500. All serial numbers are affected.

510(k) numbers

["K151525"]

PMA numbers

not on file

Product code

FKX

Firm FEI

1417572

Firm city

Deerfield

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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