BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2895454 · Received January 3, 2013

    Report

    Report Number
    2050012-2012-01978
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. THAT THEY NOTICED THE RACKS OF THE UNICEL DXC800 SYNCHRON SYSTEM (DXC 800) WERE GETTING OFF LOADED AND WERE WET WHILE RUNNING SAMPLES. CUSTOMER REPORTED THE DXC 800 WAS SQUIRTING ABOUT 4- 5 MILLILITERS OF CLEAR LIQUID ON EACH CAP. CUSTOMER REPORTED THE LEAK WAS CONTAINED ON THE CAPS AND THE RACKS. CUSTOMER REPORTED THE TOTAL VOLUME OF THE LEAK WAS LESS THAN 30 MILLILITERS. CUSTOMER REPORTED THE LEAK WAS COMING FROM THE SHOWER BLOCK. CUSTOMER REPORTED ERRONEOUS PATIENT RESULTS WERE NOT GENERATED OR REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) FOUND THE CAP PIERCER WAS LEAKING WASH SOLUTION. THE FSE FOUND THE VACUUM LINE TO THE CAP PIERCER WAS CRIMPED. THE FSE STRAIGHTENED THE LINE AND VERIFIED THE CAP PIERCER PERFORMANCE TO ENSURE NO FURTHER LEAKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2629 UNICEL DXC 800 SYNCHRON SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1