BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 1973284 · Received January 28, 2011

    Report

    Report Number
    1061932-2011-00052
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 4, 2011
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE SYSTEM ERROR MESSAGES ARE ASSOCIATED WITH THIS EVENT. IN ADDITION, THE SAMPLE HANDLER WAS NOT OPERATIONAL AND SAMPLE HANDLER SENSOR ERRORS WERE GENERATED. THE CUSTOMER CLEANED AND DISPOSED OF MATERIAL IN ACCORDANCE WITH THE LABORATORY EXPOSURE CONTROL PLAN. A BCI FIELD SERVICE ENGINEER (FSE) REMOVED, CLEANED AND LUBRICATED ALL DEAD PLATE MECHANICAL COMPONENTS. FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES. A CLEAR ROOT CAUSE CAN NOT BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A TUBES CAP THAT CAME OFF WHILE THE SAMPLE WAS BEING RUN IN THE HMX AUTOLOADER. THE EVENT OCCURRED AFTER THE CAPS WERE PIERCED, HENCE LEAKING BLOOD. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (GOWN, GLOVES AND GOGGLES). NO CHANGE TO PATIENT TREATMENT, NO DEATH, SERIOUS INJURY, OR EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS BEEN REPORTED IN ASSOCIATION WITH THIS EVENT. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER HEMATOLOGY ANALYZER, GKZ HMX AL N/A

    Patients

    Seq Age Sex Outcome Treatment
    1