BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3223181 · Received July 12, 2013

    Report

    Report Number
    1061932-2013-01454
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 15, 2013
    Report Date
    June 15, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2013 TO EVALUATE THE INSTRUMENT. THE FSE FOUND RED BLOOD COUNT (RBC) APERTURE #2 WAS LEAKING. THE FSE ALSO OBSERVED THAT THE GASKET WAS PINCHED OFF AND LOOSE. THE FSE REPOSITIONED AND TIGHTENED THE RBC BATH TO FIT INTO THE APERTURE MOUNT CORRECTLY RESOLVING THE LEAK AND THE PLT BACKGROUND ISSUE. SYSTEM WAS SUCCESSFULLY VERIFIED WITH STARTUP, QC, LATRON AND REPRODUCIBILITY. FAILURE MODE: LOOSE/PINCHED GASKET ON RBC APERTURE. THE INSTRUMENT FAILED PLT BACKGROUND UPON STARTUP ALERTING THE OPERATOR TO AN INSTRUMENT PROBLEM. PER LABELING, BECKMAN COULTER 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

    THE CUSTOMER REPORTED A GREEN COLORED FLUID (10 ML) UNDER THE LEFT SIDE OF THE COULTER® LH 750 HEMATOLOGY ANALYZER WHILE PERFORMING TROUBLESHOOTING PROCEDURES WITH BEC CUSTOMER TECHNICAL SPECIALIST (CTS) FOR FAILED STARTUP FOR PLATELET (PLT) BACKGROUNDS. THE FLUID WAS NOT CONTAINED WITHIN THE UNIT AND HAD LEAKED ONTO THE COUNTER. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT AT THE TIME OF THE EVENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED. THE LABORATORY'S EXPOSURE CONTROL/RISK MANAGEMENT PLANS ARE IN PLACE. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324362 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1