BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 PRO ANALYZER

    MDR report key: 2183448 · Received July 28, 2011

    Report

    Report Number
    2050012-2011-03322
    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
    K011213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE REQUEST WAS GENERATED BY BEC CTS (CUSTOMER TECHNICAL SUPPORT) AND A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(6) 2011. FSE FOUNF A LEAK FROM THE HYDRO AND A NOISE FROM THE PUMP BOX. FSE REPLACED THE DAMPERS FOR VACUUM PUMP AND ALSO REPLACED SPLIT TUBING ON A VALVE. FSE PRIMED INSTRUMENT 50 TIMES AND NO FURTHER LEAKING WAS OBSERVED. THE BEC INTERNAL IDENTIFIER FOR THIS EVENT IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING A LEAK COMING FROM THE HYDROPNEUMATIC OF THE SYNCHRON LX20 PRO ANALYZER. THE CUSTOMER WAS UNABLE TO DETERMINE THE SOURCE OF IDENTITY OF THE FLUID BUT IT HAD THE VISCOSITY OF WASH CONCENTRATE. THE CUSTOMER ALSO STATED THAT THE AMOUNT WAS SMALL AND THEY COULD CONTAIN THE LEAK TO PREVENT SPILLAGE ONTO THE FLOOR. NO INJURY WAS REPORTED AND NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LX20 PRO ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. LX20 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1