BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3162294 · Received June 11, 2013

    Report

    Report Number
    1416980-2013-14953
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE HOMECHOICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LABORATORY (PAL). THE DEVICE PASSED THE HC RETURN INSTRUMENT TEST/EVALUATION (RITE) ELECTRICAL TEST BUT FAILED RITE FUNCTIONAL TEST DUE TO FAILED VOLUME TRANSFERRED COMPARISON. THE DEVICE WAS RECEIVED IN OPERATIVE AND IN GOOD CONDITION. AN EXTERNAL/INTERNAL INSPECTION WAS PERFORMED AND PASSED. VOLUMETRIC ACCURACY TEST WAS PERFORMED AND THE DEVICE FAILED. TEMPERATURE CONFIRMATION TESTING WAS PERFORMED AND THE TEMPERATURE WAS VERIFIED TO BE WITHIN SPECIFICATION. INSPECTED DOOR ASSEMBLY AND FOUND A CRACKED DOOR PISTON AND DETERIORATED PISTON FOAM. THE CAUSE FOR THE RITE FAILURE OF FAILED VOLUME TRANSFERRED COMPARISON WAS DETERMINED TO BE CAUSED BY DETERIORATED PISTON FOAM. DOOR PISTON AND FOAM WERE SCRAPPED. THE DEVICE WAS SENT TO SERVICING. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP 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
    262275 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1