BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1894455 · Received November 9, 2010

    Report

    Report Number
    1423500-2010-05541
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    September 30, 2010
    Report Date
    October 18, 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). THE ACTUAL DEVICE WAS RETURNED AND EVALUATED. REVIEW OF THE DEVICE LOGS REVEALED AN INCREASED INTRAPERITONEAL VOLUME (IIPV) HAD OCCURRED WHEN THE USER DRAINED OUT 3304 ML, WHICH WAS GREATER THAN THE LARGEST PRESCRIBED FILL VOLUME OF 2000 ML AND MET IIPV CRITERIA. THE ASSIGNABLE CAUSE OF THE IIPV FOUND IN THE LOGS WAS DETERMINED TO BE: INSUFFICIENT DRAIN- FALSE EMPTY DETECT AND USE ERROR INITIAL DRAIN ALARM SETTING INAPPROPRIATELY PROGRAMMED TOO LOW (0ML) AND USE ERROR, TIDAL UF REMOVAL SET TOO LOW (0ML). A REVIEW OF THE PREVIOUS SERVICE RECORD SHOWS THE DEVICE PASSED ALL REQUIRED TESTS AND CALIBRATIONS PRIOR TO ITS RELEASE FROM THE (B)(4). NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE ISSUE OF THE 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 MACHINE, A BAXTER TECHNICIAN FOUND AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION WHICH OCCURRED ON (B)(6) 2010 DURING NITE 4 ULTRAFILTRATION, DRAIN VOLUME 3304ML. THIS EVENT MEETS THE 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