BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3873075 · Received June 13, 2014

    Report

    Report Number
    1416980-2014-18949
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WENT THROUGH EXTERNAL AND INTERNAL INSPECTION AND PASSED. AN ELECTRICAL TEST WAS PERFORMED AND PASSED. A FUNCTIONAL TEST WAS PERFORMED BUT FAILED DUE TO THERAPY MONITORED VOLUME FAILURE. THE ACCURACY CONFIRMATION TEST FAILED. A TEMPERATURE VERIFICATION TEST WAS PERFORMED AND PASSED. DEVICE POWERED UP PROPERLY AND NO ERRORS OCCURRED. THE DOOR ASSEMBLY WAS INSPECTED AND FOUND THE PISTON FOAM DETERIORATED AND CRACKED DOOR PISTON. DUE TO THE DETERIORATED PISTON FOAM THE UNIT COULD NOT DELIVER AN ACCURATE AMOUNT OF FLUID RESULTING IN THERAPY MONITORED VOLUME FAILED. THE CAUSE FOR THE RITE FAILURE OF THERAPY MONITORED VOLUME FAILED WAS DETERMINED TO BE CAUSED BY DETERIORATED PISTON FOAM. THE PISTON FOAM WAS SCRAPPED AND DEVICE WAS SENT FOR SERVICING. IF ADDITIONAL RELEVANT INFORMATION BECOMES 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. DEVICE FAILED DURING EVALUATION, NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349251 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1