BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYXZER

    MDR report key: 3163528 · Received June 11, 2013

    Report

    Report Number
    1061932-2013-01069
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 17, 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
    MI, 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 SAMPLE TUBING GOING TO THE FLOWCELL WAS LOOSE AT THE FITTING ON THE DIFFERENTIAL MIXING CHAMBER AND WAS LEAKING. THE FSE REPLACED THE TUBING AND THE LEAK WAS FIXED. THE REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES. THE CAUSE OF THE LEAK WAS THAT THE SAMPLE TUBING WAS LOOSE AT THE FITTING OF THE DIFFERENTIAL MIXING CHAMBER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) A LEAK INSIDE THE COULTER LH 750 HEMATOLOGY ANALYZER. THE VOLUME OF THE LEAK WAS ABOUT 20 ML 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 GLASSES 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 DISCREPANT PATIENT RESULTS WERE GENERATED AS A RESULT OF THIS EVENT. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263907 COULTER® LH 750 HEMATOLOGY ANALYXZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1