BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYER WITH AUTOLOADER

    MDR report key: 2280881 · Received October 6, 2011

    Report

    Report Number
    1061932-2011-01617
    Event Type
    Malfunction
    Date Received
    October 6, 2011
    Date of Event
    September 8, 2011
    Report Date
    September 8, 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
    TN, 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 RINSE BLOCK EXTENDED SLIGHTLY BEYOND THE MANUAL PROBE. THE FSE ADJUSTED THE RINSE BLOCK AND VERIFIED THE REPAIR PER ESTABLISHED PROCEDURES. BEC IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT THAT THE MANUAL PROBE IN THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER WAS LEAKING BLOODY DILUENT. NO PATIENT SAMPLES WERE AFFECTED. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) INCLUDING A GOWN, GLOVES, AND GOGGLES 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 COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. HMX WITH AUTOLOADER NA

    Patients

    Seq Age Sex Outcome Treatment
    1