BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1905090 · Received November 22, 2010

    Report

    Report Number
    1423500-2010-06103
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 30, 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 HAS BEEN RECEIVED, AND THE EVALUATION IS IN PROCESS. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WERE ALSO TWO INSTANCES OF IIPV (INCREASED INTRA-PERITONEAL VOLUME) FOUND IN THE LOGS. THE CAUSE FOR THE TWO IIPVS FOUND IN THE DEVICE LOGS 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'S SERVICE HISTORY RECORD WAS REVIEWED AND NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE IIPVS. 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 (B)(4).

    Description of Event or Problem · 1

    DURING INITIAL ASSESSMENT OF A RETURNED HOMECHOICE MACHINE, A BAXTER TECHNICIAN FOUND AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION WHICH OCCURRED ON (B)(6) 2010 DURING DRAIN CYCLE 4. THE ULTRAFILTRATION VOLUME WAS 1643ML. THIS EVENT MEETS OVERFILL CRITERIA. THIS IS REPORT 2 OF 2.

    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