BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1882130 · Received October 25, 2010

    Report

    Report Number
    1423500-2010-04905
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    September 24, 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 WAS RECEIVED AND EVALUATED. 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 AND THE RITE FUNCTIONAL TEST. THE PAL EVALUATED THE DEVICE, PERFORMED A SERVICE HISTORY REVIEW (SHR) AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE IIPV FOUND IN THE DEVICE LOG, OR SHR. THE ASSIGNABLE CAUSE OF THE IIPV WAS: INSUFFICIENT DRAIN - FALSE EMPTY DETECT AND USE ERROR, INAPPROPRIATE BYPASS OF THE LOW DRAIN VOLUME ALARM AND ONE OR MORE CYCLES ADVANCE TO NEXT FILL WHEN SLOW / NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. 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).

    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.

    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 CYCLE 9, DRAIN VOLUME 262ML. THIS EVENT MEETS OVERFILL CRITERIA. THE NURSE WAS CONTACTED. THE RESULTS OF THE EVALUATION AND THE PROBABLE CAUSE IDENTIFIED WERE PROVIDED.

    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