BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® CX5CE CLINICAL CHEMISTRY ANALYZER

    MDR report key: 1962211 · Received January 17, 2011

    Report

    Report Number
    2050012-2011-00134
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 21, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K926060
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT, FOUND, AND REPLACED THE PINCH VALVE AT THE FLOW CELL INLET AND REPLACED THE SODIUM ELECTRODE. THE FSE ALSO FOUND THAT THE REAGENT MIXER WAS NOT WORKING AND REPLACED THE MIXER MOTOR ASSEMBLY. CALIBRATION AND CONTROLS WERE THEN RUN WITH NO FURTHER ISSUES.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) STATING THAT THE FLOW CELL WAS LEAKING AROUND THE DRAIN TUBE IN THE SYNCHRON CX5CE CLINICAL CHEMISTRY ANALYZER. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® CX5CE CLINICAL CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. CX5 CE N/A

    Patients

    Seq Age Sex Outcome Treatment
    1