BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® SYSTEM

    MDR report key: 3771914 · Received April 25, 2014

    Report

    Report Number
    2050012-2014-00219
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    March 31, 2014
    Report Date
    March 31, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON FURTHER INVESTIGATION, THE FIELD SERVICE ENGINEER (FSE) DETERMINED THAT THE WASH COLLAR WASTE VALVE WAS NOT DRAINING FLUID FROM THE WASH PORT CAUSING FLUID TO LEAK OUT OF THE COLLAR WASH. THE FSE REPLACED THE WASH COLLAR WASTE VALVE TO RESOLVE THE ISSUE. IN CONCLUSION, THE CAUSE OF THE EVENT IS ATTRIBUTED TO PREMATURE FAILURE OF THE WASH COLLAR WASTE VALVE. (B)(4).

    Description of Event or Problem · 1

    WHILE TROUBLESHOOTING AN ION SELECTIVE ELECTRODE (ISE) QUALITY CONTROL (QC) ISSUE FOR THE CUSTOMER, THE FIELD SERVICE ENGINEER (FSE) DISCOVERED A LEAK FROM THE MODULAR CHEMISTRY (MC) SAMPLE PROBE WASH COLLAR OF THE UNICEL DXC 600 PRO SYNCHRON SYSTEM. THE FSE INDICATED THAT THE LEAK CONSISTED OF A DILUTED WASH SOLUTION. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF A LABORATORY COAT AND GLOVES AT THE TIME OF THE EVENT AND THERE WAS NO REPORT OF INJURY OR DIRECT EXPOSURE TO THE LEAK. ERRONEOUS RESULTS WERE NOT GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251204 UNICEL® DXC 600 PRO SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1