BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2180554 · Received July 27, 2011

    Report

    Report Number
    2050012-2011-03845
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 28, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE VISITED THE SITE ON (B)(4) 2011 AND THE FIELD SERVICE ENGINEER (FSE) NOTED A DRIP ON THE MC SAMPLE PROBE WASH COLLAR. THE FSE REPLACED THE SYRINGE T-VALVE. THE FSE RAN BLANK TUBES WITH CAPS ON THE INSTRUMENT AND FOUND THE CAP PIERCER FLOODING AND NOT DRAINING. THE FSE REMOVED A CLOT IN THE DRAIN LINE AND VERIFIED THE WASTE LINE WAS DRAINING PROPERLY. THE FSE DESCRIBED THE CLOT AS MATERIAL FROM THE WICK. THE FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES. THE ROOT CAUSE OF THE CAP PIERCER ISSUE WAS THE CLOGGED DRAIN LINE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) AND REPORTED THAT CAP PIERCER BLADE WASH CONTINUED TO LEAK ONTO TUBE CAPS ON UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM. (THE CUSTOMER'S PREVIOUS REPORT OF RELATED EVENT ON (B)(6) 2011 IS CAPTURED IN MDR #2050012-2011-03845.) THE CUSTOMER STATED NO PATIENT SAMPLES WERE RUN. MSDS WAS NOT REVIEWED, BUT THE FACILITY HAS AN EXPOSURE CONTROL PLAN. MEDICAL ATTENTION WAS NOT SOUGHT AND THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1