BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2023966 · Received March 18, 2011

    Report

    Report Number
    2050012-2011-00755
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 17, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THE MAIN VACUUM ERRORS HAVE BEEN ONGOING FOR SEVERAL DAYS AND CAUSE THE INSTRUMENT TO STOP RUNNING. CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING AND RECOMMENDED THE USE OF PERSONAL PROTECTIVE EQUIPMENT BEFORE TROUBLESHOOTING. CTS ASKED THE CUSTOMER TO INSPECT FOR LEAKS. THE CUSTOMER OPENED THE HYDRO AND SAW THAT THE NO FOAM CANISTER LID PLUG IS BUBBLING. CTS ADVISED THE CUSTOMER TO STOP THE INSTRUMENT AND THEN REMOVE AND CLEAN THE NO FOAM PLUG. THE CUSTOMER STATED THIS NO FOAM CANISTER WAS RECENTLY REPLACED AND THAT THE THREADS LOOK OK. THE BUBBLES IN NO FOAM CONTINUE TO FORM AFTER CLEANING. A BCI FIELD SERVICE ENGINEER (FSE) REBUILT PUMPS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT NO FOAM BUBBLING FROM THE BOTTLE CAP AND LEAKING. THE LEAKING HARDWARE MAY CAUSE INCORRECT RESULTS OR OPERATOR EXPOSURE TO CHEMICALS OR BIOHAZARDS UPON REOCCURRENCE. NO INJURY OR EXPOSURE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER, JJE BECKMAN COULTER INC. DXC600P N/A

    Patients

    Seq Age Sex Outcome Treatment
    1