BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH750 HEMATOLOGY ANALYZER

    MDR report key: 3033747 · Received April 3, 2013

    Report

    Report Number
    1061932-2013-00499
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: THE PORTS ON THE WASTE CHAMBER NEEDED TO BE CLEANED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER THAT THE COULTER LH 750 HEMATOLOGY ANALYZER LEAKED APPROXIMATELY 20 ML OF FAINT BLUE FLUID. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT AND WAS FOUND UNDER THE INSTRUMENT. THE CUSTOMER WAS WEARING A LAB COAT AND GOGGLES AT THE TIME OF THE OCCURRENCE. THERE WAS NO REPORT OF INJURY OR EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES, AND THE CUSTOMER DID NOT SEEK MEDICAL ATTENTION. THE CUSTOMER DID NOT REVIEW THE MATERIAL SAFETY DATA SHEET (MSDS), BUT THERE IS AN EXPOSURE CONTROL PLAN IN PLACE AT THE FACILITY. NO ERRONEOUS PATIENT RESULTS WERE GENERATED AND THERE WAS NO IMPACT TO PATIENT TREATMENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) FOUND THE WASTE CHAMBER, VC26, WAS OVERFLOWING, WHICH CAUSED DILUENT TO LEAK. THE FSE CLEANED THE PORTS ON VC26 AND RESOLVED THE LEAK. VC26 IS A WASTE CHAMBER WHICH COLLECTS WASTE FROM THE FLOW CELL. THE FSE VERIFIED SERVICE ACTIVITY PERFORMED PER ESTABLISHED PROCEDURES, AND THE RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136609 COULTER® LH750 HEMATOLOGY ANALYZER DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER LH750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1