BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYXZER

    MDR report key: 3112562 · Received May 14, 2013

    Report

    Report Number
    1061932-2013-00825
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 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
    CA
    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 TUBING FROM CHECK VALVE (PV2B) HAD COME OFF AND DILUENT WAS LEAKING OUT OF THE ANALYZER. THE TUBING COMES FROM THE BACKWASH TANK TO PV2B AND DELIVERS DILUENT TO THE HEMOGLOBIN (HGB) CUVETTE. THE FSE REPLACED THE TUBING AND SECURED IT TO THE PV2B THAT FIXED THE LEAK . THE FSE PERFORMED BACKWASH TANK CHECK, AND HGB BLANK ADJUSTMENT TO ENSURE THAT DILUENT WAS BEING DELIVERED TO THE HGB CUVETTE AND NO ADDITIONAL FLUID LEAKS WAS OCCURRING. FAILURE MODE WAS DETACHED TUBING AT CHECK VALVE (PV2B). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER A LEAK OF CLEAR LIQUID FROM THE COULTER LH 750 HEMATOLOGY ANALYZER. THE VOLUME OF LEAK WAS 16 OZ. AND WAS CONTAINED WITHIN THE INSTRUMENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS REVIEWED. THERE IS AN EXPOSURE CONTROL PLAN AT THE FACILITY. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), INCLUDING A LABORATORY COAT, GOGGLES AND GLOVES. NO ONE WAS SPLASHED, SPRAYED OR INJURED. THERE WAS NO CONTACT TO OPEN OR BROKEN SKIN OR MUCOUS MEMBRANES. NO ONE SOUGHT MEDICAL ATTENTION. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR EFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212526 COULTER® LH 750 HEMATOLOGY ANALYXZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1