BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3923864 · Received July 9, 2014

    Report

    Report Number
    1416980-2014-21985
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 16, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS EVALUATED AND THE ISSUE WAS IDENTIFIED THROUGH REVIEW OF THE EVENT HISTORY LOGS. THE CAUSE WAS DETERMINED TO BE ONE OR MORE CYCLES ADVANCING TO NEXT FILL WHEN SLOW / NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. ALL RETURNED HOMECHOICE DEVICES RECEIVE A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDES FUNCTIONAL AND ELECTRICAL TESTING ON THE DEVICE. THE DEVICE FAILED FUNCTIONAL RITE FOR NO DISPLAY. THE FUNCTIONAL RITE FAILURE FOUND WILL BE CAPTURED IN A DIFFERENT COMPLAINT. THE DEVICE ALSO RECEIVED AN INTERNAL/EXTERNAL INSPECTION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2014 AT 07:42. DURING CYCLE FOUR, THE DRAIN VOLUME WAS 4351ML WITH A LARGEST PRESCRIBED FILL VOLUME OF 2500ML. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402049 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1