BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2150004 · Received July 5, 2011

    Report

    Report Number
    2050012-2011-02832
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    June 5, 2011
    Report Date
    June 5, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THE FIELD SERVICE ENGINEER (FSE) ARRIVED ON-SITE (B)(4) 2011, THE BUBBLING HAD STOPPED. THE CUSTOMER ALSO COMPLAINED OF "LOW 17 PSI ERRORS AND BUBBLES COMING OUT OF WASH CONCENTRATE SUPPLY BOTTLE" TO THE FSE AT TIME OF SERVICE. FSE STOPPED AND HOMED THE INSTRUMENT AND EMPTIED THE WASH CONCENTRATE AND WASH SOLUTION CANISTERS. FSE OBSERVED THE SYSTEM SUCCESSFULLY FILL BOTH CANISTERS WITH NO PROBLEMS. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REPORTING THAT THEY WERE HAVING ISSUES WITH THE WASH CONCENTRATE BOTTLE BUBBLING WITH A SMALL CONTAINED OVERFLOW IN THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM. NO INJURY WAS REPORTED AND NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1