BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1972857 · Received January 28, 2011

    Report

    Report Number
    1423500-2011-01198
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    December 14, 2010
    Report Date
    January 6, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: THE DEVICE PASSED THE HOMECHOICE RETURN INSTRUMENT TEST / EVALUATION FUNCTIONAL AND ELECTRICAL TESTS AND WAS FUNCTIONING WITHIN SPECIFICATION. THE ROOT CAUSE OF THE INCREASE INTRAPERITONEAL VOLUME (IIPV) FOUND IN THE DEVICE LOGS WAS INSUFFICIENT DRAIN - ONE OR MORE CYCLES ADVANCE TO NEXT FILL WHEN SLOW / NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED, AND THE EVALUATION IS IN PROCESS. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION WAS IDENTIFIED IN THE LOG OF A RETURNED HOMECHOICE DEVICE. THE IIPV OCCURRED ON (B)(6) 2010 DURING DRAIN CYCLE 4. THE PROGRAMMED FILL VOLUME WAS 1700ML AND THE ULTRAFILTRATION WAS 1959 ML . THIS VOLUME MEETS BAXTER'S IIPV CRITERIA. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR