BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 3241565 · Received July 22, 2013

    Report

    Report Number
    1061932-2013-01487
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 2, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 INSPECTED THE INSTRUMENT AND HAD OBSERVED THAT THE SOURCE OF THE LEAK WAS THE LOWER SHEATH TUBING HAD POPPED OFF OF ITS FLOWCELL FITTING. THE FSE DRIED AND REPLACED THE TUBING. RADIO FREQUENCY (RF) VOLTAGE ERRORS WERE NOT OBSERVED BY THE FSE. FOLLOWING THE REPAIR, NO FURTHER EVIDENCE OF LEAKING WAS OBSERVED. THE CAUSE OF THE LEAK WAS A DISCONNECTED TUBING AT THE LOWER SHEATH RESTRICTOR. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT THE COULTER LH 780 HEMATOLOGY ANALYZER WAS EXPERIENCING RADIO FREQUENCY (RF) VOLTAGE ERRORS AND WAS LEAKING WHILE CUSTOMER WAS ATTEMPTING TO RUN A STARTUP. THE VOLUME OF THE LEAK IS UNKNOWN AND THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED BY THE CUSTOMER. THE LABORATORY¿S EXPOSURE CONTROL/RISK MANAGEMENT PLANS ARE IN PLACE. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), CONSISTING OF GLOVES, EYE PROTECTION, AND A LABORATORY COAT AT THE TIME OF THE OCCURRENCE. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO ONE CAME IN CONTACT WITH THE FLUID. MEDICAL ATTENTION WAS NOT SOUGHT. NO ERRONEOUS RESULTS WERE GENERATED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340047 COULTER® LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH780 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1