BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYXZER

    MDR report key: 3081399 · Received April 26, 2013

    Report

    Report Number
    1061932-2013-00661
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE FOUND THAT THE CUSTOMER HAD RESOLVED THE ISSUE BEFORE HIS ARRIVAL. THE SOURCE OF THE LEAK WAS THE TUBING AT THE DIFFERENTIAL SHEAR VALVE (CVL 85/126). THE CUSTOMER HAD REPLACED THE AFFECTED TUBING. THE FSE VERIFIED THE REPAIR AND ENSURED INSTRUMENT FUNCTIONALITY. THERE WAS NO FURTHER EVIDENCE OF LEAKING OBSERVED. THE CAUSE OF THE LEAK WAS THE TUBING AT THE DIFFERENTIAL SHEAR VALVE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER THAT THE COULTER LH 750 HEMATOLOGY ANALYZER WAS LEAKING CLEAR FLUID. THE VOLUME OF THE LEAK WAS APPROXIMATELY 5ML AND WAS CONTAINED WITHIN THE INSTRUMENT. IT COULD NOT BE CONFIRMED IF THE INSTRUMENT GENERATED ANY ERROR MESSAGES OR FLAGS AS A RESULT OF THIS EVENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED. THE LABORATORY'S EXPOSURE CONTROL/RISK MANAGEMENT PLANS ARE IN PLACE. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), CONSISTING OF GLOVES, GOGGLES, AND A LABORATORY COAT AT THE TIME OF THE OCCURRENCE. NO ONE CAME IN CONTACT WITH THE FLUID. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. MEDICAL ATTENTION WAS NOT SOUGHT. NO ERRONEOUS RESULTS WERE GENERATED AS A RESULT OF THIS EVENT. THERE WAS NO DEATH OR INJURY REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181138 COULTER® LH 750 HEMATOLOGY ANALYXZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1