BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® CLINICAL SYSTEM (PACKAGED)

    MDR report key: 2232124 · Received September 1, 2011

    Report

    Report Number
    2050012-2011-04768
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 5, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BEC CTS (CUSTOMER TECHNICAL SUPPORT) ASSISTED CUSTOMER TO REMOVE AND CLEAN THE FLOAT SWITCH SENSOR AND RESEAT THE SWITCH SENSOR. CTS ALSO ASSISTED THE CUSTOMER WITH ADJUSTING THE PRESSURE. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND REPLACED THE VACUUM AND PRESSURE PUMP DUE TO THE LOW VACUUM ERRORS AND THE SYSTEM WAS RESUMED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING A FLUID LEAK UNDER THE UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM. PER CUSTOMER, THE FLUID APPEARED SOAPY.THE INSTRUMENT WAS FLAGGED WITH PRESSURE ERRORS. THE CUSTOMER OBSERVED THE DI (DEIONIZED) WATER RESERVOIR WAS EMPTY AND THE WASH SOLUTION CANISTER WAS OVERFILLED.NO INJURY OR EXPOSURE WAS REPORTED AND NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1