{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "169658", "product_res_number": "Z-0849-2019", "event_date_initiated": "2018-12-11", "event_date_created": "2019-02-20", "recall_status": "Terminated", "event_date_terminated": "2021-02-12", "res_event_number": "81738", "product_code": "FKX", "k_numbers": [ "K151525" ], "product_description": "AMIA Automated Peritoneal Dialysis System \n\nProduct Usage:\nIt is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis.", "code_info": "Product code 5C9320. All serial numbers are affected for devices distributed from 02/11/2016 through 11/27/2018.", "firm_fei_number": "1417572", "recalling_firm": "Baxter Healthcare Corporation", "address_1": "1 Baxter Pkwy", "city": "Deerfield", "state": "IL", "postal_code": "60015-4625", "additional_info_contact": "888-736-2543", "reason_for_recall": "Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy", "root_cause_description": "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. \n\nProviders 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. \n\nPatients 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", "product_quantity": "7,688 devices", "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. \n\nDistributed internationally to Canada and Japan.", "openfda": { "k_number": [ "K212522", "K844630", "K933687", "K830766", "K872652", "K123630", "K832141", "K181108", "K840224", "K823303", "K811986", "K831766", "K830689", "K842885", "K823390", "K822361", "K002892", "K902149", "K791342", "K823217", "K822547", "K895336", "K222318", "K830257", "K201867", "K830208", "K823330", "K923065", "K935659", "K141145", "K822658", "K053512", "K833065", "K103220", "K844144", "K173718", "K820179", "K830881", "K884554", "K822025", "K822712", "K823777", "K841929", "K243371", "K171652", "K833595", "K833749", "K901477", "K771484", "K822546", "K822545", "K810683", "K844108", "K874632", "K823296", "K250523", "K822549", "K822548", "K822544", "K862928", "K220935", "K831716", "K850406", "K845042", "K124018", "K905809", "K823331", "K901478", "K151525", "K772150", "K823857", "K823827", "K842305", "K012988", "K043363", "K901228", "K910173", "K994218", "K822550", "K102936", "K212658", "K813487", "K822543" ], "registration_number": [ "", "1650907", "3039353681", "3012536737", "3015309643", "1225714", "3038277270", "3002907620", "3010421104", "1724474", "3015882716", "3033589330", "9680579", "3015335038", "9610270", "3031565407", "3038195011", "2030624", "1721676", "3003537036", "9612057", "3015225571", "9680340", "1721504", "3006194679", "3003504604", "9612052", "3006755813", "2133641", "1649518", "3003865400", "1319639", "2314912", "3004111573", "3006950086", "3030306055", "2132111", "3012494290", "3032828299", "8030638", "8030665" ], "fei_number": [ "", "3039353681", "3012536737", "3003094851", "3002806727", "3000203466", "3002807744", "3015309643", "3038277270", "3002907620", "3002806460", "1000434163", "1000138054", "3010421104", "1000203464", "3002681132", "3015882716", "3033589330", "3015335038", "3001451489", "3038195011", "3012394756", "3000206435", "1721676", "3003537036", "3015225571", "1721504", "3002806443", "3006194679", "3003504604", "3006755813", "1000140026", "3003865400", "2314912", "3004111573", "3006950086", "3030306055", "3012494290", "3032828299", "3001236277", "3031565407" ], "device_name": "System, Peritoneal, Automatic Delivery", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5630", "device_class": "2" } } ] }