BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2230309 · Received September 1, 2011

    Report

    Report Number
    2050012-2011-04755
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 1, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 AND INSPECTED THE HYDRO CANISTERS AND MOISTURE SEPARATORS WITH NO ISSUES FOUND. THE FSE ALSO ENABLED THE CHEMISTRY CARTRIDGE (CC) SIDE AND PERFORMED A STOP/HOME CYCLE. LOW/HIGH PRESSURES WERE ADJUSTED INTO THEIR RANGES. THE FSE ALSO PRIMED THE INSTRUMENT WITH NO ERRORS. QC WAS TESTED BY THE CUSTOMER FOR VERIFICATION; NO ISSUES WERE NOTED BY FSE. REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES PRIOR TO RETURNING THE INSTRUMENT INTO SERVICE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING A HYDRO ERROR OCCURRENCE AND A LEAK THAT WAS OBSERVED IN THE HYDRO AREA IN THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE CUSTOMER INDICATED THAT WASTE HAD BACKED UP INTO THE PRIMARY VACUUM ACCUMULATOR. CUSTOMER STATED THEY PULLED THE VACUUM ACCUMULATOR AND THE WASTE EXIT SUMP. FLUID WAS FOUND IN THE DRYERS. NO INJURY WAS REPORTED IN THIS EVENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 800 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1