BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3941164 · Received July 17, 2014

    Report

    Report Number
    1416980-2014-22980
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    May 31, 2014
    Report Date
    June 23, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO BAXTER AND THE EVALUATION IS COMPLETE. THIS IS AN ANCILLARY SERVICE EVENT. THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED THROUGH AN EVENT HISTORY LOG REVIEW. THE HOMECHOICE DEVICE RECEIVED A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDED FUNCTIONAL AND ELECTRICAL TESTING OF THE DEVICE. THE CAUSE WAS DETERMINED TO BE AN INSUFFICIENT DRAIN DUE TO ONE OR MORE CYCLES ADVANCING TO NEXT FILL WHEN SLOW / NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT 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 23:59:34. DURING NIGHT DRAIN CYCLE FOUR, THE PATIENT'S ULTRAFILTRATION READING WAS 1537ML, INDICATING THE HOME PATIENT (HP) DRAINED 1537ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 2500ML. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418858 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR