BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2232111 · Received September 1, 2011

    Report

    Report Number
    2050012-2011-04800
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SHUT DOWN THE DXC UNIT AND REBOOTED IT. THE CUSTOMER ALSO TRACED THE LINE DOWN TO THE BLOCK AND CLEANED THE BLOCK. THE LEAKING CONTINUED. THE CUSTOMER THEN CLEANED THE PROBE, CHECKED THE WASH COLLAR AND FLUSHED THE BLOCK. THE MODULAR CHEMISTRY (MC) PROBE AND WASH COLLAR WERE STILL LEAKING. A SERVICE REQUEST WAS GENERATED.A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(6) 2011 AND FOUND MC WASTE VALVE AND ANOTHER VALVE BETWEEN WASTE SUMP AND WASTE EXIT SUMP WERE NOT WORKING AND REPLACED THEM. FSE RETURNED ON-SITE (B)(6) 2011 AFTER CUSTOMER NOTED THAT HYDRO WAS LEAKING AND FOUND THAT ONE VALVE WAS NOT PROPERLY SWITCHING BETWEEN PRESSURE AND VACUUM CAUSING THE MAIN WASTE SUMP TO BACK UP. FSE ALSO FOUND NO FOAM VALVE HAD FAILED, CONTRIBUTING TO THE PROBLEM. FSE REPLACED BOTH THE VALVES AND VERIFIED PROPER OPERATION OF THE WASTE SYSTEM AND CALIBRATED CHEMISTRIES AS NEEDED AND RAN QC. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT THE MODULAR CHEMISTRY (MC) SAMPLE PROBE AND WASH COLLAR IN THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM WERE NOT ASPIRATING PROPERLY AND WATER WAS RUNNING DOWN THE PROBE. NO INJURY OR EXPOSURE WAS REPORTED AND NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1