BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1884422 · Received October 27, 2010

    Report

    Report Number
    1423500-2010-04997
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Date of Event
    September 28, 2010
    Report Date
    October 7, 2010
    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). THE DEVICE WAS DETERMINED TO MEET FUNCTIONAL AND ELECTRICAL PERFORMANCE SPECIFICATION REQUIREMENTS PER RITE TESTING. THE DEVICE PASSED BOTH THE HOMECHOICE RETURN INSTRUMENT TEST / EVALUATION (RITE) ELECTRICAL TEST (B)(4) AND THE RITE FUNCTIONAL TEST (B)(4). REVIEW OF THE DEVICE LOGS REVEALED A VOLUME OF FLUID MEETING INCREASED INTRAPERITONEAL VOLUME (IIPV) CRITERIA; ON (B)(6) 2010 IN CYCLE 5 THE USER HAD A DRAIN VOLUME OF 3666 ML. THIS DRAIN VOLUME IS GREATER THAN 160% OF THE LARGEST PRESCRIBED FILL VOLUME OF 2200 ML AND MET IIPV CRITERIA. THE PRODUCT ANALYSIS LABORATORY EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE IIPV FOUND IN THE DEVICE LOGS. THE DEVICE FUNCTIONED NORMALLY DURING TESTING. THE ASSIGNABLE CAUSE OF THE IIPV ON (B)(6) 2010 WAS DETERMINED TO BE: INSUFFICIENT DRAIN, ONE OR MORE CYCLES ADVANCES TO NEXT FILL WHEN SLOW / NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. THE DEVICE WAS SUBSEQUENTLY FORWARDED TO SERVICE. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH CAPA INVESTIGATION (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

    DURING INITIAL ASSESSMENT OF A HOMECHOICE DEVICE, A BAXTER TECHNICIAN IDENTIFIED TWO INCREASED INTRAPERITONEAL VOLUME (IIPV) EVENTS. THIS IS REPORT 1 OF 2 WHICH OCCURRED ON DATE (B)(6) 2010 DURING DRAIN CYCLE 5. THE DRAIN VOLUME WAS 3666ML. THE PROGRAMMED FILL VOLUME WAS 2200ML. THIS EVENT MEETS OVERFILL CRITERIA.

    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 67 YR