BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1863950 · Received October 11, 2010

    Report

    Report Number
    1423500-2010-04289
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 17, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RECEIVED OPERATIONAL AND IN GOOD CONDITION. THE DEVICE FAILED THE HOMECHOICE RITE (RETURN INSTRUMENT TEST / EVALUATION) FUNCTIONAL TEST FOR VOLUMETRIC ACCURACY DURING FILL 1, DRAIN 1, FILL 2 & DRAIN 2 BUT PASSED THE RITE ELECTRICAL TEST. ACTUAL RITE RESULTS: FILL 1 = 823.9, DRAIN 1 = 823.7, FILL 2 = 824.6, DRAIN 2 = 824.3 ML (ACCURACY LIMITS: 774.0 - 821.0 ML). THE PRODUCT ANALYSIS LAB (PAL) EVALUATED THE DEVICE AND IT PASSED THE TEMPERATURE VERIFICATION TEST BUT FAILED THE VOLUMETRIC CONFIRMATION TEST. THE PISTON FOAM WAS REPLACED AND THE DEVICE PASSED THE VOLUMETRIC CONFIRMATION TEST. NO PROBLEMS WERE FOUND DURING AN INTERNAL INSPECTION. THE CAUSE FOR RITE TEST FAILURE - VOLUMETRIC ACCURACY DURING FILL 1, DRAIN 1, FILL 2 & DRAIN 2 WAS DETERMINED TO BE DETERIORATED PISTON FOAM. THE DEVICE'S SERVICE HISTORY RECORD WAS REVIEWED AND NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE RITE FAILURE. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    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.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE (HC) DEVICE, THE PRODUCT ANALYSIS LABORATORY DETERMINED THE HC MACHINE SYSTEM FAILED RETURNED INSTRUMENT TEST/EVALUATION TESTING DUE TO: THERAPY MONITORED VOLUME FAILED PERFORMANCE SPECIFICATION FAILING FILL 1 AND 2 AND DRAIN 1 AND 2.

    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 67 YR