BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2770384 · Received October 3, 2012

    Report

    Report Number
    1061932-2012-02527
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 7, 2012
    Report Date
    September 7, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2012 AND FOUND THE TUBING UNDER THE FLOW CELL CAME OFF. THE FSE REPLACED THE TUBING UNDER THE FLOW CELL TO REPAIR THE LEAK. THE NEXT DAY ((B)(4) 2012) THE TUBING POPPED OFF AGAIN, SO THE FSE RETURNED AND REPLACED THE TUBING AGAIN AND INCLUDED A SLEEVE ON THE TUBING. FAILURE MODE IS THE TUBING ON THE BOTTOM PORT OF THE FLOW CELL THAT HAD POPPED OFF. PER LABELING, BECKMAN COULTER, INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) TO REPORT A LEAK WAS ON THE COUNTER UNDER THE COULTER LH 750 HEMATOLOGY ANALYZER AND WAS UNABLE TO DETERMINE THE SOURCE. THE LEAK WAS TOWARDS THE RIGHT SIDE OF THE INSTRUMENT AND APPEARED TO CONSIST OF A 1/4 CUP OF DILUENT MIXED WITH BLOOD. THE LEAK WAS FOUND AND CLEANED BY THE EVENING SHIFT WHILE PERFORMING A SHUTDOWN\STARTUP. THE OPERATOR WAS WEARING PERSONAL PROPER EQUIPMENT (PPE), CONSISTING OF A LAB COAT, FACE SHIELD, AND GLOVES. THE CUSTOMER DID NOT REPORT ANY EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. NO ERRONEOUS RESULTS WERE GENERATED OR REPORTED DURING THIS TIME. THE CUSTOMER DID NOT REPORT ANY ERRORS AS THE INSTRUMENT WAS IN THE MIDDLE OF A SHUTDOWN\STARTUP (SAMPLES WERE NOT BEING PROCESSED DURING THIS PERIOD). NO TYPE OF ERROR WAS REPORTED BY THE INSTRUMENT WHEN THE FLUID LEAK WAS OBSERVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other