BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2334016 · Received November 11, 2011

    Report

    Report Number
    2050012-2011-07219
    Event Type
    Malfunction
    Date Received
    November 11, 2011
    Date of Event
    October 14, 2011
    Report Date
    October 14, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE WASH CONCENTRATE CANISTER ON THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM DID NOT FILL IN TIME AND THERE WAS "ILLEGAL SWITCH" CONDITIONS FOR THE WASH CONCENTRATE CANISTER. CUSTOMER REPORTED THAT FLUID HAS LEAKED FROM THE RESERVIOR AND IS FORMING CRYSTALS ON CANISTER AND IN THE HYDROPNEUMATIC TRAY. CUSTOMER REPORTED THAT ERRONEOUS RESULTS WERE NOT GENERATED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) REPLACED THE 2-WAY VALVE AND CHECKED THE FLOAT SWITCH. THE FSE REPORTED THAT THE SUB-SYSTEM WAS PERFORMING WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXC 600I NA

    Patients

    Seq Age Sex Outcome Treatment
    1