BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYER WITH AUTOLOADER

    MDR report key: 2243151 · Received September 12, 2011

    Report

    Report Number
    1061932-2011-01410
    Event Type
    Malfunction
    Date Received
    September 12, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 12, 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
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THE EVENT. THE FSE NOTICED THAT THE BELLOWS WERE NOT DRAINING DUE TO POOR VENTING. THE FSE CHANGED THE VENTING PATHWAY TO THE VACUUM WASTE CHAMBER. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE NEEDLE BELLOWS ON THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER WERE NOT DRAINING. THE LEAK DRIPPED ONTO THE COUNTER AND THE FLOOR. NO PATIENT SAMPLES WERE AFFECTED NOR WERE ERRONEOUS RESULTS REPORTED OUT OF THE LABORATORY. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) AT THE TIME OF THE INCIDENT. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® HMX HEMATOLOGY ANALYER WITH AUTOLOADER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. HMX WITH AUTOLOADER NA

    Patients

    Seq Age Sex Outcome Treatment
    1