BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX5 DELTA CLINICAL SYSTEM

    MDR report key: 2183451 · Received July 28, 2011

    Report

    Report Number
    2050012-2011-03323
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 29, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K881495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BEC CTS (CUSTOMER TECHNICAL SUPPORT) ADVISED THE CUSTOMER TO TURN OFF THE HYDROPNEUMATIC AND CHECK THE WASH SOLUTION BOTTLE CAP. THE CAP WAS NOT LOOSE AND ALL THE TUBINGS WERE INTACT. ANOTHER LEAK WAS OBSERVED UNDER THE HYDROPNEUMATIC AND BROWN FLUID WAS PRESENT. CTS GENERATED A SERVICE REQUEST. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(6) 2011 AND TRACED LEAK TO WASH SOLUTION BOTTLES. FSE FOUND A DEFECTIVE CHECK VALVE LEAKING AND REPLACED THE VALVE. INSTRUMENT WAS PRIMED AND REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES. NO FURTHER LEAKING WAS OBSERVED. THE BEC INTERNAL DENTIFER FOR THIS EVENT IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING THAT A CLEAR FLUID WAS COMING OUT OF THE WASH SOLUTION BOTTLE IN THE SYNCHRON CX5 DELTA CLINICAL SYSTEM. THE CUSTOMER STATED IT APPEARED TO BE OVERFLOWING AND ESCAPING FROM THE CAP. NO INJURY WAS REPORTED AND NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CX5 DELTA CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. CX5 DELTA NA

    Patients

    Seq Age Sex Outcome Treatment
    1