BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1880282 · Received October 22, 2010

    Report

    Report Number
    1423500-2010-04804
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 16, 2010
    Report Date
    October 1, 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 BOTH THE HOMECHOICE RETURN INSTRUMENT TEST / EVALUATION (RITE) ELECTRICAL TEST (B)(4) AND THE RITE FUNCTIONAL TEST (B)(4). REVIEW OF THE DEVICE LOGS REVEALED AN ADDITIONAL DIFFICULTY OF AN INCREASED INTRAPERITONEAL VOLUME (IIPV) HAD OCCURRED ON (B)(6) 2010 DURING CYCLE 4 WHEN THE DEVICE USER DRAINED OUT 4037 ML, WHICH WAS GREATER THAN THE LARGEST PRESCRIBED FILL VOLUME OF 2500 ML AND MET IIPV CRITERIA. THE PAL EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE IIPV FOUND IN THE DEVICE LOGS. THE ASSIGNABLE CAUSE OF THE ADDITIONAL IIPV FOUND IN THE DEVICE LOGS WAS DETERMINED TO BE: INSUFFICIENT DRAIN- USE ERROR, TIDAL UF REMOVAL SET TOO LOW. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RTB-CAPA-(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 HOMECHOICE DEVICE, A BAXTER TECHNICIAN IDENTIFIED AN INCREASED INTRAPERITONEAL VOLUME (IIPV) EVENT WHICH OCCURRED ON (B)(6) 2010, DURING DRAIN CYCLE 4, THE DRAIN VOLUME WAS 4037 MILLILITERS (ML). 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