BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® CX5 DELTA CLINICAL SYSTEM

    MDR report key: 2192374 · Received August 4, 2011

    Report

    Report Number
    2050012-2011-04235
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K950958
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) FOUND A LEAKING CHECK VALVE AND REPLACED THE VALVE. AS OF (B)(6) 2011, THERE WAS NO FURTHER CALL FROM THE CUSTOMER. BEC INTERNAL IDENTIFIER FOR THIS COMPLAINT IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A FLUID LEAK FROM HYDRO AREA ON SYNCHRON CX5 DELTA CLINICAL SYSTEM. MSDS WAS NOT REVIEWED, BUT THE FACILITY HAS EXPOSURE CONTROL PLAN. MEDICAL ATTENTION WAS NOT SOUGHT 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 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. CX5 DELTA NA

    Patients

    Seq Age Sex Outcome Treatment
    1