BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 3112554 · Received May 14, 2013

    Report

    Report Number
    1061932-2013-00821
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT 20 ML OF GREEN FLUID HAD LEAKED UNDER THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED BY THE CUSTOMER. THERE IS AN EXPOSURE CONTROL/RISK MANAGEMENT PLAN IN PLACE AT THE FACILITY. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), CONSISTING OF GLOVES AND A LABORATORY COAT WHEN THE LEAK WAS OBSERVED. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. THERE WAS NO IMPACT TO PATIENT RESULTS. NO DEATH OR INJURY IS ATTRIBUTED TO THIS EVENT AND THERE WAS NO CHANGE TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212212 COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER N/A

    Patients

    Seq Age Sex Outcome Treatment
    1