BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2923095 · Received January 18, 2013

    Report

    Report Number
    1416980-2013-01442
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 26, 2012
    Report Date
    December 26, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE FAILED HC RETURN INSTRUMENT TEST/EVALUATION (RITE) ELECTRICAL TEST DUE TO A FAILED EARTH LEAKAGE CURRENT TEST AND A FAILED RITE FUNCTIONAL TEST. FLUID INTRUSION WAS FOUND TO HAVE CAUSED THE PUMP ASSEMBLY TO MALFUNCTION, WHICH PREVENTED THE PUMP ASSEMBLY FROM ACTIVATING. THIS RESULTS IN THE FAILED EARTH LEAKAGE CURRENT TEST.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE (HC) DEVICE, A BAXTER TECHNICIAN DETERMINED THE HC MACHINE FAILED THE EARTH LEAKAGE CURRENT (LC) TEST. THE EARTH LC NORMAL WAS OVER THE SPECIFICATION LIMIT. THE EARTH LC SINGLE FAULT NORMAL WAS OVER THE SPECIFICATION LIMIT. THE EARTH LC SINGLE FAULT REVERSE WAS OVER THE SPECIFICATION LIMIT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27219 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1