BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 2192389 · Received August 5, 2011

    Report

    Report Number
    1061932-2011-01118
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT. THE FSE CLEANED THE SPILL AND VERIFIED NEEDLE ALIGNMENT. THE FSE ALSO FOUND BLOOD FROM THE SAMPLE TUBE HAD SEEPED BETWEEN THE BELT AND THE ROCKERBED PREVENTING THE ROCKERBED FROM ADVANCING. THE ROOT CAUSE IS UNKNOWN TO DATE. 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 IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ANALYZER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT THE CAP FROM THE SPECIMEN TUBE CAME OFF DURING SAMPLE ASPIRATION AT THE PIERCING STATION CAUSING BLOOD TO SPILL ONTO THE ROCKERBED OF THE COULTER LH 780 HEMATOLOGY ANALYZER. THE CUSTOMER INDICATED THAT THE INSTRUMENT ROCKERBED WOULD NOT ADVANCE. THE OPERATOR WAS WEARING THE APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT (PPE) WHEN THE INCIDENT OCCURRED - GLOVES, LAB COAT, AND GLASSES. THERE WAS NO BLOOD EXPOSURE TO MUCOUS MEMBRANES (NOSE, EYE AND MOUTH) OR OPEN WOUNDS AND NO ONE SOUGHT MEDICAL ATTENTION. PATIENT TREATMENT WAS NOT AFFECTED AS A RESULT OF THIS EVENT. BEC IDENTIFIER FOR THIS REPORT IS (B)(4).

    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