BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1884165 · Received October 27, 2010

    Report

    Report Number
    1423500-2010-04976
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Date of Event
    September 21, 2010
    Report Date
    October 5, 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 MEDWATCH WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE WAS RECEIVED AND EVALUATED. THE RITE (RETURN INSTRUMENT TEST/EVALUATION) TEST WAS PERFORMED WHEN THE DEVICE WAS RETURNED TO THE BAXTER (B)(4) FACILITY FOR EVALUATION. THE DEVICE PASSED THE HOMECHOICE RITE FUNCTIONAL TEST ((B)(4)) AND THE HOMECHOICE RITE ELECTRICAL TEST ((B)(4)). DURING THE PAL EVALUATION A SHORT SIMULATED THERAPY WAS PERFORMED AND COMPLETED SUCCESSFULLY. CRT (CYCLER REMOTE TOOLBOX) SOFTWARE INDICATED ALL PRESSURES WERE CORRECT AND STABLE. THE COVER WAS OPENED AND AN INTERNAL INSPECTION PERFORMED. NO PROBLEMS WERE REVEALED DURING THIS INSPECTION AND ALL CONNECTIONS WERE CORRECT AND SECURE. THE IIPV WAS CONFIRMED IN THE LOGS, BUT NOT DUPLICATED DURING PAL EVALUATION. THE ROOT CAUSE IS INSUFFICIENT DRAIN; ONE OR MORE CYCLES ADVANCE TO NEXT FILL WHEN SLOW / NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. SERVICE HISTORY REVIEW REVEALED THE PREVIOUS RETURN OF THE DEVICE WAS NOT FOR ANY ISSUES RELATED TO IIPV. 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 DEVICE, A BAXTER TECHNICIAN IDENTIFIED AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WHICH OCCURRED ON (B)(6) 2010 DURING DRAIN CYCLE 3. THE DRAIN VOLUME WAS 3418 ML. THIS EVENT MEETS OVERFILL CRITERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR