BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1862056 · Received October 8, 2010

    Report

    Report Number
    1423500-2010-04171
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    July 20, 2010
    Report Date
    September 16, 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 PASSED THE RETURN RITE ELECTRICAL TEST AND WAS FOUND TO MEET ELECTRICAL SPECIFICATIONS BUT FAILED THE RITE FUNCTIONAL TEST. THE LAB EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED IIPV FOUND IN THE DEVICE LOGS. THE CAUSE OF THE IIPV WAS DETERMINED TO BE: INSUFFICIENT DRAIN CAUSED BY USE ERROR, TIDAL UF REMOVAL SET TOO LOW. PRODUCT SURVEILLANCE FOLLOWED UP WITH THE NURSE AND PROVIDED THE RESULTS OF EVALUATION THE NURSE WILL CHECK THE SETTINGS ON THE PATIENT'S HOMECHOICE DEVICE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. 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 (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION EXPECTED BUT NOT YET COMPLETED. ANY RESULTS OF EVALUATION WILL BE PROVIDED IN A FOLLOW UP EMDR.

    Description of Event or Problem · 1

    DURING INITIAL ASSESSMENT OF A RETURNED HOMECHOICE DEVICE, A BAXTER TECHNICIAN IDENTIFIED AN INCREASED INTRAPERITONEAL VOLUME (IIPV) EVENT WHICH OCCURRED ON (B)(6) 2010 DURING DRAIN CYCLE 5. THE DRAIN VOLUME WAS 3045 ML (MILLILITERS). 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