BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2902114 · Received January 8, 2013

    Report

    Report Number
    1416980-2013-00521
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 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 EARTH LEAKAGE AND FAILED RITE FUNCTIONAL TEST. THE ASSIGNABLE CAUSE FOR THE RITE FAILURE OF EARTH LEAKAGE WAS A MALFUNCTIONING PUMP ASSEMBLY DUE TO FLUID INTRUSION.

    Description of Event or Problem · 1

    DURING THE EVALUATION OF A RETURNED HOMECHOICE (HC) DEVICE, A BAXTER TECHNICIAN DETERMINED THE HC MACHINE FAILED THE EARTH LEAKAGE CURRENT TEST. THE EARTH LC NORMAL WAS 989.0 MICROAMP WITH A SPECIFICATION LIMIT BETWEEN 4.0 - 300.0 MICROAMPS. THE EARTH LC SINGLE FAULT NORMAL WAS 989.0 MICROAMP WITH A SPECIFICATION LIMIT BETWEEN 4.0 - 500.0 MICROAMPS. THE EARTH LC SINGLE FAULT REVERSE WAS 989.0 MICROAMP WITH A SPECIFICATION LIMIT BETWEEN 4.0 - 500.0 MICROAMPS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8886 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1