BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 1843253 · Received September 24, 2010

    Report

    Report Number
    2050012-2010-00863
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 23, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON CALL BACK ON (B)(4) 2010, THE CUSTOMER SAID THAT THE FUMES WERE NOT COMING FROM INSTRUMENT FLUID WASTE, FUMES AND BAD ODOR WAS COMING FROM AN UNKNOWN CHEMICAL STORED IN BOTTLE IN THE BOTTOM OF THE SINK. THE CUSTOMER WAS ABLE TO REMOVE THE CHEMICAL AND RESOLVE THE ISSUE. THE CUSTOMER ADJUSTED THE SINK DRAIN LINE APPROPRIATELY.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING WASTE LEAKING BETWEEN THE DRAIN HOSE AND SINK. THE CUSTOMER ALSO COMPLAINED OF FUMES IN THE LAB FROM THE WASTE. NO INJURY WAS REPORTED. NO PERSONNEL WERE EXPOSED TO THE FLUID WASTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1