BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® CX5 DELTA CLINICAL SYSTEM

    MDR report key: 2030078 · Received March 25, 2011

    Report

    Report Number
    2050012-2011-00849
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K950958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE VISITED ON (B)(4) 2011, AND THE FIELD SERVICE ENGINEER (FSE) FOUND THE INSTRUMENT WAS LEAKING WASH CONCENTRATE 2. THE FSE REPLACED THE WASH BUFFER BOTTLE AND CHANGED THE FILTER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A FLUID LEAK FROM SYNCHRON CX5 DELTA CLINICAL SYSTEM. THE CUSTOMER STATED THE LEAK WAS FROM THE BOTTOM OF THE HYDRO DRAWER. THE FLUID WAS IN DARK COLOR THAT CONGEALED INTO A HARD TARRY SUBSTANCE. THE CUSTOMER STATED THAT THIS SEEMED TO HAVE BEEN GOING ON FOR A WHILE AS CHASSIS APPEARED CORRODED. CUSTOMER HAS AN EMERGENCY SPILL PLAN IN PLACE IN THE LAB AND ACCESS TO MSDS. NO INJURY WAS REPORTED AND THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1