BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 3885252 · Received June 19, 2014

    Report

    Report Number
    2050012-2014-00289
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 24, 2014
    Report Date
    May 24, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE EVALUATED THE INSTRUMENT AND NOTED THAT THE BLADE WASH STATION WAS NOT DRAINING. THE FSE INSPECTED CAP PIERCER WASTE LINE # (B)(4), DISCONNECTED THE QUICK CONNECT FITTING, AND OBSERVED A BUILDUP ON THE QUICK DISCONNECT. THE FSE RECONNECTED THE LINE AND VACUUM RETURNED. THE FSE VERIFIED PROPER DRAINAGE AND OPERATION OF THE CAP PIERCER AND NO FURTHER ISSUES WERE NOTED. THE CAUSE OF THE EVENT IS ATTRIBUTED TO THE QUICK CONNECT FITTING AND THE FSE RESOLVED THE ISSUE BY RECONNECTING THE FITTING. INCIDENTALLY, THE FSE DISCOVERED A KINKED TUBING WHICH RESTRICTED THE FLOW OF AUTOGLOSS CAUSING THE CAP PIERCER BLADES TO BREAK. THE FSE REPLACED THE AUTOGLOSS TUBING, WICK AND BLADE TO RESOLVE THE ISSUE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN OVERFLOW FROM THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM AS A RESULT OF THE CAP PIERCER BLADE WASH CUP NOT DRAINING. THE CUSTOMER STATED THAT FLUID LEAKED FROM THE WASH CUP DOWN TO THE SAMPLE RACKS AND TUBES. THE VOLUME OF THE LEAK IS UNKNOWN BUT THE CUSTOMER INDICATED THAT THE LEAK WAS CONTAINED TO THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF A LABORATORY COAT, GLOVES, AND PROTECTIVE EYEWEAR 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
    360487 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1