BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2172706 · Received July 22, 2011

    Report

    Report Number
    2050012-2011-03330
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 15, 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
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2011, BEC FIELD SERVICE ENGINEER (FSE) FOUND THE CAP-PIERCER NOT FUNCTIONING CORRECTLY. THE BLADE WASH STATION SEAL SHUTTLE WAS NOT MOVING CORRECTLY BACK-AND-FORTH ON THE CAP PIERCER ALIGNMENT ARM. THE FSE REPLACED ASSOCIATED PARTS: TS-CTS ARM ASSEMBLY, ELBOW SWIVEL FITTING, CAM FOLLOWER ASSEMBLY, AND NEW WASH STATION SEAL SHUTTLE WITH A NEW QUAD RING. THE PART REPLACEMENTS RESOLVED THE LEAK ISSUE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT A PROBE OBSTRUCTION ERROR ON A UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM THAT WERE CAUSED BY THE CAP PIERCER. THE BLADE CAME DOWN ON THE BLACK PLATFORM WHERE THE BLADE IS WASHED AND BROKE THE SEAL ON THE WASH STATION CAUSING WASH SOLUTION TO LEAK. THE CUSTOMER STATED THERE WAS NO EXPOSURE AND MEDICAL ATTENTION WAS NOT SOUGHT. NO EFFECT TO PATIENT OR OPERATOR WAS REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1