BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® CX9 ALX CLINICAL SYSTEM

    MDR report key: 2092377 · Received May 18, 2011

    Report

    Report Number
    2050012-2011-01812
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 20, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K950958
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND PERFORMED SERVICE ON THE INSTRUMENT AND OBSERVED A LEAK COMING FROM THE DRAIN LINE THAT CONNECTS FROM THE BULKHEAD WALL TO THE HYDRO DRAIN CANISTER. THE FSE STATED THAT THE HOSE WAS DETERIORATING. THE FSE REPLACED THE LINE AND PRIMED THE INSTRUMENT WITH NO LEAKS OBSERVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT A YELLOW FLUID WAS LEAKING ON THE CX4 SIDE OF THE SYNCHRON CX9 ALX CLINICAL SYSTEM. CUSTOMER WAS UNABLE TO IDENTIFY WHERE THE LEAK WAS COMING FROM. NO INJURY OR OPERATOR EXPOSURE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® CX9 ALX CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. CX9 ALX N/A

    Patients

    Seq Age Sex Outcome Treatment
    1