BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYXZER

    MDR report key: 3180784 · Received June 20, 2013

    Report

    Report Number
    1061932-2013-01130
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 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
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE ON (B)(4) 2013. THE FSE INSPECTED THE INSTRUMENT AND DISCOVERED THAT THE TUBING FROM THE NEEDLE TO FLUID DETECTOR FD1 WAS LOOSE AT THE FITTING OF THE FLUID DETECTOR AND WAS LEAKING. THE FSE REPLACED THE TUBING AND THE INSTRUMENT RAN WITHOUT ANY LEAKS. THE REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES. THE CAUSE OF THE LEAK WAS THAT THE TUBING FROM THE NEEDLE TO FLUID DETECTOR FD1 WAS LOOSE AT THE FITTING OF THE FLUID DETECTOR. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) A LEAK AT THE BLOOD SAMPLING VALVE (BSV) OF THE COULTER LH 750 HEMATOLOGY ANALYZER. THE VOLUME OF THE LEAK WAS ABOUT 3 ML AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE LEAK DID NOT IMPACT ELECTRICAL OR OPTICAL PERFORMANCE OF SYSTEM. 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 GLASSES 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 DISCREPANT PATIENT RESULTS WERE GENERATED IN CONNECTION WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279573 COULTER® LH 750 HEMATOLOGY ANALYXZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1