BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 2923493 · Received January 22, 2013

    Report

    Report Number
    1061932-2013-00070
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 21, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER RESOLVED THE ISSUE THROUGH TROUBLESHOOTING VIA THE TELEPHONE. THE SOURCE OF THE FLUID LEAK WAS IDENTIFIED TO BE THE TUBING PASSING THROUGH PINCH VALVE, VL46B. THE CUSTOMER REPLACED THE TUBING AND RESOLVED THE ISSUE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY TEN (10) MILLILITERS OF CLEAR FLUID LEAKED OUTSIDE THE INSTRUMENT FROM THE LOWER SHEATH RESTRICTOR TUBING INVOLVING THE COULTER LH 780 HEMATOLOGY ANALYZER. THE CUSTOMER HAD ON PROPER PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, A LABORATORY COAT, AND FACE SHIELD AND DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. PATIENT RESULTS WERE NOT IMPACTED. ALL QUALITY CONTROL RESULTS WERE WITHIN THE ACCEPTABLE LIMITS. THE CUSTOMER HAS AN EXPOSURE CONTROL/RISK MANAGEMENT PLAN AT THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30088 COULTER® LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1