BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3243973 · Received July 23, 2013

    Report

    Report Number
    1061932-2013-01574
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 2, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER RESOLVED THE ISSUE THROUGH SYSTEM TROUBLESHOOTING. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FLUID LEAKED UNDER THE INSTRUMENT NEAR THE MANUAL PROBE AREA INVOLVING THE COULTER LH 750 HEMATOLOGY ANALYZER. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT 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. THERE WAS NO PATIENT CONSEQUENCE ASSOCIATED WITH THIS EVENT. THE CUSTOMER REPLACED DAMAGED/CUT TUBING TOWARD THE BLOOD SAMPLING VALVE (BSV) AND RESOLVED THE FLUID LEAK ISSUE. SYSTEM STARTUP AND ALL CONTROLS PASSED WITHIN SPECIFICATIONS. THE FACILITY HAS AN EXPOSURE CONTROL AND RISK MANAGEMENT PLAN IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343079 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1