BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 2671858 · Received July 26, 2012

    Report

    Report Number
    1061932-2012-02195
    Event Type
    Malfunction
    Date Received
    July 26, 2012
    Date of Event
    July 5, 2012
    Report Date
    July 5, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED, AS THE CUSTOMER'S BIOMEDICAL ENGINEER REPLACED THE WORN TUBING AT PINCH VALVE PV49 AND RESOLVED THE LEAK ISSUE. THE INSTRUMENT WAS IN OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY TWENTY (20) MILLILITERS OF DILUENT LEAKED FROM PV49 TUBING, OUTSIDE THE INSTRUMENT AND ONTO THE COUNTER INVOLVING COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER. THE CUSTOMER HAD ON PROPER PERSONAL PROTECTIVE EQUIPMENT (PPE), CONSISTING OF GLOVES, A LABORATORY COAT, AND EYE PROTECTION DURING THE EVENT. THE CUSTOMER HAS AN EXPOSURE CONTROL/RISK MANAGEMENT PLAN AT THE FACILITY. PATIENT RESULTS WERE NOT IMPACTED. THE CUSTOMER DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO EXPOSURE TO OPEN LESIONS OR MUCOUS MEMBRANES. THERE WAS NO REPORT OF OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1