BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 2040453 · Received April 5, 2011

    Report

    Report Number
    1061932-2011-00236
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 7, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS NOT WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE). PER PRODUCT LABELING, BECKMAN COULTER, INC., URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THERE WAS NO NEED FOR FIRE EXTINGUISHER OR FOR SUMMONING THE FIRE DEPARTMENT. A FIELD SERVICE ENGINEER WAS DISPATCHED AND REPLACED THE COMPRESSOR. THE HMX AL ANALYZER IS COMPLIANT WITH THE FOLLOWING SAFETY RATINGS - (B)(4). ROOT CAUSE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) AND REPORTED A BURNING SMELL COMING FROM THE PNEUMATIC POWER SUPPLY MODULE CAUSED BY CLENZ OVERFLOWING INTO THE COMPRESSOR ON COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER. THERE WAS NO EXPOSURE, OR CONTACT TO EYES OR SKIN, OPEN WOUNDS OR MUCOUS MEMBRANES TO THE CLEANER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. HMX WITH AUTOLOADER

    Patients

    Seq Age Sex Outcome Treatment
    1