BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3241947 · Received July 22, 2013

    Report

    Report Number
    1416980-2013-19377
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    May 19, 2013
    Report Date
    June 27, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND EVALUATED. THIS IS AN ANCILLARY SERVICE EVENT. THE REPORTED DIFFICULTY OF AN IIPV EVENT WAS CONFIRMED THROUGH AN EVENT HISTORY LOG REVIEW. THE CAUSE WAS ONE OR MORE CYCLE ADVANCES TO THE NEXT FILL WHEN A SLOW / NO FLOW OCCURRED, ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED. THIS OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2013, DURING NIGHT DRAIN CYCLE SIX. THE PATIENT'S ULTRAFILTRATION READING WAS 1141ML, INDICATING THE HOME PATIENT (HP) DRAINED 1141ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 1700ML. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341854 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR