BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1872003 · Received October 17, 2010

    Report

    Report Number
    1423500-2010-04533
    Event Type
    Malfunction
    Date Received
    October 17, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 23, 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).DEVICE EVALUATION IS CURRENTLY IN PROGRESS. ANY RESULTS OF EVALUATION WILL BE PROVIDED IN A FOLLOW UP E MDR.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE FAILED THE HOMECHOICE RITE (RETURN INSTRUMENT TEST / EVALUATION) FUNCTIONAL TEST FOR HEATER BAG TEMPERATURE TEST, BUT PASSED THE RITE ELECTRICAL TEST. THE PAL PERFORMED A METHOD 3 EVALUATION. THE TEMP ON FEATURE OF THE CRT (CYCLER REMOTE TOOLBOX) SOFTWARE WAS USED TO DIAGNOSE THE HEATER SYSTEM. NO PROBLEMS WERE ENCOUNTERED. NO ISSUES WITH THE HEATER SYSTEM WERE ENCOUNTERED DURING THE METHOD 3 EVALUATION. THE ASSIGNABLE CAUSE FOR RITE TEST FAILURE - HEATER BAG TEMPERATURE TEST WAS UNDETERMINED. THE DEVICE'S SERVICE HISTORY RECORD WAS REVIEWED AND NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE RITE FAILURE. THE DEVICE WILL BE SERVICED. 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 INITIAL ASSESSMENT OF A RETURNED HOMECHOICE (HC) DEVICE, THE PRODUCT ANALYSIS LABORATORY DETERMINED THE HC MACHINE SYSTEM FAILED RETURNED INSTRUMENT TEST/EVALUATION TESTING DUE TO A HEATER BAG TEMPERATURE FAILED PERFORMANCE SPECIFICATION-FLUID DELIVERED OUT OF SPECIFICATIONS.

    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