BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN COULTER ¿ COULTER ® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2823350 · Received November 7, 2012

    Report

    Report Number
    1061932-2012-02633
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 16, 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, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2012, A FIELD SERVICE ENGINEER (FSE) WAS ON SITE AND FOUND RESIDUAL FLUID IN THE BOTTOM OF TRAY CAUSED BY IMPROPERLY ROUTED SAMPLE LINE. THE SAMPLE LINE MAY CARRY BLOOD CONTROLS, LH SERIES PAK (ERYTHROLYSE AND STABILYSE), LH RIECK PAK (RETIC STAIN AND CLEARING SOLUTION), AND DILUENT; AND CLEANER DURING SHUTDOWN. THE FSE DID NOT NOTE ANY ACTIVE LEAKS. THE FSE DID NOT NOTE APPROXIMATELY THREE DRIPS INTO THE TRAY WHICH WERE CONTAINED. THE FSE DID NOT NOTE ANY FLUIDS ON THE OUTSIDE OF THE INSTRUMENT. THE FSE ALSO ADDRESSED THE ROCKER BED STRIPPER PLATE INTERMITTENT ERROR AND THE FOLLOWING OTHER ITEMS: PUMP EXCESSIVE NOISE. REPLACED ROCKER BED AIR CYLINDER. REPLACED DIAPHRAGM PUMP. REPLACED SAMPLE LINE TO AVOID FUTURE KINK IN LINE. REPLACED DIFF SAMPLE LINE. ADJUSTED CYLINDER PRESSURE. ON (B)(4) 2012 THE FSE PROVIDED ADDITIONAL INFORMATION, STATING THE SAMPLE LINE APPEARED TO HAVE BEEN ACCIDENTALLY MOVED PRIOR TO SERVICE. THE FSE RAN APPROPRIATE VERIFICATION CHECKS WHICH WERE ACCEPTABLE. THE FAILURE MODE OF THE EVENT WAS THE IMPROPERLY ROUTED SAMPLE LINE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN UNCONTAINED BLOODY FLUID LEAK BY THE FLOW CELL ON THEIR COULTER LH 750 HEMATOLOGY ANALYZER. THE CUSTOMER NOTICED THE LEAK AS THEY WERE RUNNING PATIENT SAMPLES. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LAB COAT, EYE PROTECTION, AND GLOVES. THE CUSTOMER DID NOT COME IN CONTACT WITH THE FLUID AND DID NOT SEEK MEDICAL ATTENTION. NO EXPOSURE (SPRAYED OR SPLASHED) TO MUCOUS MEMBRANES OR OPEN WOUNDS WERE REPORTED, NO DEATH, INJURY OR EXPOSURE WAS REPORTED. PATIENT RESULTS WERE NOT AFFECTED BY THIS EVENT. THE CUSTOMER DID NOT REVIEW THE MSDS; HOWEVER, THE FACILITY DOES HAVE A RISK MANAGEMENT/EXPOSURE CONTROL PLAN IN PLACE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1