BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS CLINICAL SYSTEM

    MDR report key: 3203188 · Received July 2, 2013

    Report

    Report Number
    2050012-2013-00433
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND DISCOVERED A FULL OVERFLOW WASTE CONTAINER AND FLUID FLOWED BACK THROUGH THE WASH STATION TUBING. THE FSE EMPTIED THE OVERFLOW WASTE CONTAINER TO RESOLVE THE LEAK. THE FSE STATED THAT A DEFECTIVE CTA (CLOSED TUBE ALIQUOTER) WASH STATION STARTED LEAKING FLUID ON (B)(4) 2013 AND THE FSE WAS DISPATCHED TO RESOLVE THE ISSUE. PLEASE REFER TO MEDWATCH REPORT # 2050012-2013-00416 FOR THE REPORT OF THE EVENT WHICH OCCURRED ON (B)(4) 2013. THE FSE REPLACED THE DEFECTIVE CTA WASH STATION TO RESOLVE THE ISSUE BUT INADVERTENTLY FAILED TO DRAIN THE WASTE OVERFLOW CONTAINER, WHICH WAS DESIGNED TO CAPTURE ANY OVERFLOW FROM THE CTA WASH STATION, DURING THE CTA WASH STATION REPLACEMENT. RESULTS: FAILURE MODE IS ATTRIBUTED TO AN OVERFILLED OVERFLOW CTA WASH STATION WASTE CONTAINER. BECKMAN COULTER INTERNAL IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NOTICING A WASH BUFFER LEAK WHICH POOLED UNDERNEATH THE ALIQUOT PROBE WASH STATION INVOLVING THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM WHILE TROUBLESHOOTING LEVEL SENSE ERRORS ON THE CTA (CLOSED TUBE ALIQUOTER). THE CUSTOMER INDICATED THAT APPROXIMATELY 2 ML OF WASH BUFFER WAS PIPETTED OUT OF THE WASH TOWER AND A SMALL POOL OF FLUID HAD COLLECTED UNDERNEATH THE WASH STATION. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES AND A LABORATORY COAT AT THE TIME OF THE EVENT AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS PATIENT RESULTS WERE 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
    302622 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