BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX5 DELTA

    MDR report key: 2080735 · Received May 6, 2011

    Report

    Report Number
    2050012-2011-01531
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 8, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K942676
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) FOUND A LEAK COMING FROM THE WASTE TOWER TUBING WHERE A FILTER WAS MISSING. THE FSE INSERTED A PIECE FOR FILTER MATERIAL AND PRIMED THE INSTRUMENT, BUT LEAKING CONTINUED. PER FSE DIAGNOSIS, IT WAS AN OCCLUDED "WASTE BUCKET". THE FSE REMOVED SOME PROTEIN BUILD-UP AND FLUSHED WITH DI WATER. THE FSE PRIMED THE INSTRUMENT AND NO FURTHER LEAKS DETECTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REPORTING A LIQUID ON TOP OF THE PLEXIGLASS THAT COVERS THE ELECTRONICS IN THE HYDRO OF THE SYNCHRON CX5 DELTA INSTRUMENT. THE CUSTOMER BELIEVED IT WAS WASH SOLUTION. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE). NO INJURY WAS REPORTED ON THIS ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1