BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2951126 · Received February 8, 2013

    Report

    Report Number
    1061932-2013-00164
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TUBING GOING THROUGH PINCH VALVE (VL9) IS THE PATHWAY FOR WHOLE BLOOD ASPIRATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BLOOD LEAKING OUT OF THE LEFT HAND OF THE COULTER LH 750 HEMATOLOGY ANALYZER BEHIND WHERE THE AUTOMATION LINE ARM CONNECTS. THE CUSTOMER INDICATED THAT THE VOLUME OF THE LEAK WAS LESS THAN 30 ML AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LAB COAT ALONG WITH THE OPERATOR'S PERSONAL EYE GLASSES AT THE TIME OF THE EVENT AND NO EXPOSURE OR INJURY WAS REPORTED. NO ERRONEOUS RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THE EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND OBSERVED A SMALL HOLE IN THE TUBING GOING THROUGH PINCH VALVE (VL9). THE FSE CLEANED THE SPILL AND REPLACED THE AFFECTED TUBING AND SLEEVE. NO FURTHER EVIDENCE OF LEAKING WAS OBSERVED AND ISSUE WAS RESOLVED FOLLOWING SERVICE. FAILURE MODE WAS DETERMINED TO BE A SMALL HOLE IN THE TUBING AT VL9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54081 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1