BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 2094441 · Received May 19, 2011

    Report

    Report Number
    1061932-2011-00442
    Event Type
    Injury
    Date Received
    May 19, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 FOR THIS EVENT. THE FSE REMOVED AND DISSEMBLED THE ROCKER BED TO THOROUGHLY CLEAN THE DRIED BLOOD FROM THE ASSEMBLY AND THE NEEDLE PIERCE MECHANISM. THE ROOT CAUSE IS ATTRIBUTED TO USER ERROR WHILE SERVICING THE INSTRUMENT. PER LABELING: TO AVOID INJURY: TAKE FULL ADVANTAGE OF THE SAFETY FEATURES OF THE INSTRUMENT. DO NOT DEFEAT SAFETY INTERLOCKS AND SENSORS. USE THE PROPER TOOLS WHEN TROUBLESHOOTING.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE OPERATOR'S FINGER WAS PIERCED BY THE SAMPLE NEEDLE DURING CLEAN UP OF A BLOOD SPILL ON THE COULTER LH 780 HEMATOLOGY ANALYZER. THE BLOOD SPILL OCCURRED AS CONSEQUENCE OF CAPS BEING SEPARATED FROM THE SAMPLE TUBES DURING SAMPLE ASPIRATION ON THE INSTRUMENT, WHICH IS REPORTED IN MDR 1061932-2011-00424. THE OPERATOR WAS TREATED IN THE EMERGENCY ROOM WHERE THE WOUND WAS CLEANED AND BLOOD WAS DRAWN TO PERFORM BASELINE TESTING. THE HEPATITIS VACCINE WAS NOT ADMINISTERED, AS THE OPERATOR HAD ALREADY RECEIVED THE VACCINE AND THE ER STAFF DID NOT FEEL THAT AN HIV ELIXIR WAS NECESSARY. THE OPERATOR WAS BACK TO WORK THE FOLLOWING DAY AND WAS FEELING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 780 HEMATOLOGY ANALYZER HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. LH 780 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other