BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMIA AUTOMATED PD CYCLER SET

    MDR report key: 16146393 · Received January 12, 2023

    Report

    Report Number
    1416980-2022-07365
    Event Type
    Malfunction
    Date Received
    January 12, 2023
    Report Date
    February 20, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    PMA / PMN Number
    K151525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5: IT WAS CLARIFIED THAT THE PATIENT WAS USING AMIA AUTOMATED SET WITH CASSETTE. D1: BRAND NAME: ADDED, CHANGE FROM NI. D4: CATALOGUE #: WAS CHANGED FROM ASKU TO 5C5479. G1: ADDED THE NAME AND ADDRESS FOR THE DEVICE MANUFACTURER; REMOVE: BAXTER HEALTHCARE - DOMINICAN REPUBLIC. CARRETERA SANCHEZ KM 18.5, PARQUE INDUSTRIAL ITABO, PIISA. HAINA SAN CRISTOBAL DOMINICAN REPUBLIC (INITIALLY REPORTED AS A POTENTIAL LOCATION IN H10). G4: PMA/510K # OR BLA #: WAS CHANGED FROM NI TO K151525. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    MANUFACTURING FACILITY - THIS DEVICE WAS MANUFACTURED AT ONE OF THE TWO FOLLOWING MANUFACTURING SITES: BAXTER HEALTHCARE - MOUNTAIN HOME, 1900 N HIGHWAY 201, MOUNTAIN HOME, AR 72653 UNITED STATES. BAXTER HEALTHCARE - DOMINICAN REPUBLIC, CARRETERA SANCHEZ KM 18.5, PARQUE INDUSTRIAL ITABO, PIISA, HAINA SAN CRISTOBAL, DOMINICAN REPUBLIC. THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROTECTIVE CAPS ON AN UNSPECIFIED QUANTITY OF HOMECHOICE AUTOMATED PD CYCLER SETS WERE LOOSE. THIS WAS OBSERVED PRIOR TO USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512579 AMIA AUTOMATED PD CYCLER SET SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown