BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMIA PD MACHINE

    MDR report key: 15079455 · Received July 20, 2022

    Report

    Report Number
    MW5111041
    Event Type
    Malfunction
    Date Received
    July 20, 2022
    Date of Event
    July 11, 2022
    Report Date
    July 19, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING PERITONEAL DIALYSIS, PD MACHINE CEASED TO WORK AND ALARM BEGAN TO SOUND. CLINICAL STAFF UNABLE TO UTILIZE ASPECTS OF THE MACHINE INCLUDING TOUCH SCREEN, POWER BUTTON, AND ALARM SILENCE BUTTON. BATTERY REMOVED FROM MACHINE AND UNPLUGGED. NEW MACHINE OBTAINED AND SET UP TO UTILIZE FOR PATIENT APPROPRIATELY TO RESTART PD TREATMENT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88509 AMIA PD MACHINE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female