BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 4250182 · Received November 14, 2014

    Report

    Report Number
    1416980-2014-40272
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 20, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND AN EVALUATION WAS PERFORMED TO INVESTIGATE THE REPORTED PROBLEM. A REVIEW OF THE SERVICE HISTORY REVEALED NO PREVIOUS SERVICE EVENTS THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM. THE DEVICE FAILED AN INTERNAL AND EXTERNAL VISUAL INSPECTION DUE TO AN UNRELATED ISSUE. THE HOMECHOICE DEVICE RECEIVED A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDED FUNCTIONAL AND ELECTRICAL TESTING OF THE DEVICE. THE DEVICE FAILED THE ELECTRICAL TESTING FOR RITE - GROUND BOND FAILED PERFORMANCE SPEC AND ALSO FAILED THE RITE FUNCTIONAL TESTING FOR AN UNRELATED ISSUE. THE DIRECT CAUSE OF THE PROBLEM WAS THE DOOR GROUND WIRE WAS FOUND DISCONNECTED FROM THE MAIN GROUND POST. THE DOOR GROUND WAS RECONNECTED TO RESOLVE THE PROBLEM. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: CMPLNT-(B)(4). THE HOMECHOICE WAS RETURNED AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. 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 DEVICE, A BAXTER TECHNICIAN DETERMINED THE DEVICE FAILED RITE (RETURNED INSTRUMENT TEST/EVALUATION) TESTING FOR THE GROUND BOND TEST INDICATING A HIGH RESISTANCE VALUE BETWEEN THE HOMECHOICE AND THE GROUND BOND ON THE POWER SUPPLY. THE DEVICE FAILED DURING EVALUATION WITH NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736826 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1