BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3073675 · Received April 23, 2013

    Report

    Report Number
    1061932-2013-00631
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 29, 2013
    Report Date
    March 29, 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
    LA, 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 HAD OBSERVED THAT THE SOURCE OF THE LEAK WAS AT THE PROBE WIPE ASSEMBLY. THE FSE REPLACED THE AFFECTED PROBE WIPE ASSEMBLY. NO FURTHER EVIDENCE OF LEAKING WAS OBSERVED. THE CAUSE OF THE LEAK WAS THE PROBE WIPE ASSEMBLY. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER THAT THE COULTER LH 750 HEMATOLOGY ANALYZER WAS LEAKING. THE VOLUME OF THE LEAK WAS APPROXIMATELY 8 ML AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE ANALYZER DID NOT GENERATE 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 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 IN CONNECTION WITH THIS EVENT. THERE WAS NO DEATH OR INJURY RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173326 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1