BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3923848 · Received July 9, 2014

    Report

    Report Number
    1416980-2014-21984
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    May 31, 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). METHOD: THE DEVICE WAS RETURNED TO BAXTER AND THE EVALUATION IS COMPLETE. THIS COMPLAINT IS AN ANCILLARY SERVICE EVENT. THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED THROUGH AN EVENT HISTORY LOG REVIEW. ALL RETURNED HOMECHOICE DEVICES RECEIVE A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDES FUNCTIONAL AND ELECTRICAL TESTING ON THE DEVICE. THE HOMECHOICE PASSED ALL RITE ELECTRICAL TESTING, HOWEVER, FAILED RITE FUNCTIONAL TESTING FOR NO DISPLAY. UPON CONCLUSION OF THE INVESTIGATION, THE CAUSE WAS DETERMINED TO BE ONE OR MORE CYCLES WERE ADVANCED TO THE NEXT FILL BY THE PATIENT WHEN THE DRAIN WAS SLOW OR NOT FLOWING ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP 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, 21:00:29. DURING NIGHT DRAIN CYCLE FOUR, THE DRAIN VOLUME WAS 3939ML WITH A MAXIMUM PROGRAMMED FILL VOLUME OF 2500ML. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401083 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR