BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3994194 · Received August 8, 2014

    Report

    Report Number
    1416980-2014-25714
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 16, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE (HC) DEVICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB (PAL). THE EXTERNAL/INTERNAL INSPECTION WAS PERFORMED AND FOUND A MELTED CONNECTOR AT THE ACCOMP PRINTED CIRCUIT BOARD POWER HARNESS. THE TEMPERATURE WAS WITHIN SPECIFICATIONS. THE DEVICE PASSED ELECTRICAL TESTING. A VOLUMETRIC ACCURACY TEST WAS PERFORMED AND THE DEVICE FAILED. IT WAS DETERMINED THAT THE TEST FAILED DUE TO A SYSTEM ERROR (SE) 0002. WHEN THE POWER ON THE DEVICE WAS CYCLED, THE DEVICE ALARMED AND HAD A FLASHING CURSOR ON THE SCREEN. THE CAUSE OF THE SE AND THE FLASHING CURSOR WAS DETERMINED TO BE INTERMITTENT OPERATION OF THE DIGITAL PCB DUE TO A POOR CONNECTION. THE ACCOMP PRINTED CIRCUIT BOARD AND POWER HARNESS WERE TO BE SCRAPPED AND THE DEVICE SENT FOR SERVICING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE (HC) DEVICE, A BAXTER TECHNICIAN DETERMINED THE HC MACHINE FAILED FLUID VOLUME ACCURACY TESTING. THE DEVICE FAILED DURING EVALUATION WITH NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467709 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1