BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3221136 · Received July 11, 2013

    Report

    Report Number
    1416980-2013-18016
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING EVALUATION OF THE RETURNED DEVICE, THE DEVICE HAD PASSED THE HOMECHOICE (HC) RETURNED INSTRUMENT TEST/EVALUATION (RITE) ELECTRICAL TEST BUT FAILED RITE FUNCTIONAL TEST DUE TO FAILED VOLUME TRANSFERRED COMPARISON. DURING RITE FUNCTIONAL TESTING FLUID WAS TRANSFERRED ABOVE THE RITE SPECIFIED LIMITS DURING FILL 1. AS A RESULT, THE DEVICE FAILED VOLUMETRIC ACCURACY TEST. THE DEVICE HAD PASSED EXTERNAL AND INTERNAL INSPECTIONS. ALSO, THE DEVICE HAD PASSED THE TEMPERATURE CONFIRMATION TESTING. DURING THE INSPECTION, PISTON FOAM WAS FOUND TO BE DETERIORATED, WHICH WOULD NOT ALLOW THE PROPER AMOUNT OF FLUID TO BE DELIVERED. THE ROOT CAUSE OF THE RITE FAILURE OF FAILED VOLUME TRANSFERRED COMPARISON IS DETERMINED TO BE DETERIORATED PISTON FOAM. THEREFORE, THE FOAM PISTON WAS DISCARDED. DEVICE WAS SENT FOR SERVICING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE (HC) DEVICE, IT WAS DETERMINED THAT THE HC MACHINE SYSTEM HAD FAILED THE RETURNED INSTRUMENT TEST/EVALUATION (RITE) TESTING DUE TO RITE THERAPY MONITORED VOLUME FAILED PERFORMANCE SPEC. DEVICE FAILED DURING EVALUATION, NO PATIENT INVOLVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319809 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1