BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1891888 · Received November 5, 2010

    Report

    Report Number
    1423500-2010-05355
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 12, 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). EVALUATION SUMMARY: THE RITE (RETURN INSTRUMENT TEST/EVALUATION) TEST WAS PERFORMED WHEN THE DEVICE WAS RETURNED TO THE BAXTER (B)(4) FACILITY FOR EVALUATION. THE DEVICE FAILED THE HOMECHOICE RITE FUNCTIONAL TEST DUE TO FAILING THE ACCURACY TEST IN FILL 1. THE HOMECHOICE RITE ELECTRICAL TEST PASSED. THE ASSIGNABLE CAUSE FOR THE RITE ACCURACY FAILURE WAS UNDETERMINED. THE PREVIOUS RETURN OF THE DEVICE WAS NOT FOR ANY DIFFICULTIES RELATED TO THE RITE FUNCTIONAL TEST FAILED FOR THERAPY MONITOR VOLUME ACCURACY. 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.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE (HC) DEVICE, THE (B)(6) LABORATORY DETERMINED THE HC MACHINE SYSTEM FAILED RETURNED INSTRUMENT TEST/EVALUATION TESTING DUE TO THE DEVICE MAY DELIVER INACCURATE FLUID VOLUME LEADING TO UNDER OR OVERFILL DURING FILL 1.

    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