BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2752707 · Received September 20, 2012

    Report

    Report Number
    1061932-2012-02412
    Event Type
    Malfunction
    Date Received
    September 20, 2012
    Date of Event
    August 26, 2012
    Report Date
    August 27, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE REPLACED THE O-RINGS ON WBC APERTURE #3 AND THE FITTING THAT SECURES IT INTO PLACE IN THE APERTURE HOUSING. THE FSE PRIMED APERTURES AND VERIFIED THAT THE WBC BATH REMAINED DRY UNDER THE APERTURES. THE FSE ALSO FLUSHED OUT THE UPPER FITTING CONNECTING THE COUNT LINE TO THE TOP OF THE HOUSING. THE CAUSE OF THE LEAK WAS RELATED TO THE O-RINGS ON WBC APERTURE #3. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC) AND REPORTED A DILUENT LEAK UNDER THE WHITE BLOOD CELL (WBC) BATH OF THE COULTER LH 750 HEMATOLOGY ANALYZER WHILE RUNNING A STARTUP. THE LEAK WAS CONTAINED. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, GOGGLES AND A LAB COAT AT THE TIME OF THE EVENT. THERE WAS NO INJURY OR BIOHAZARD EXPOSURE. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. THERE WAS NO IMPACT TO PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1