BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2895723 · Received January 3, 2013

    Report

    Report Number
    1061932-2013-00010
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 7, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED LESS THAN TWO (2) MILLILITERS OF DILUENT AND CLENZ CLEANING SOLUTION LEAKED ON THE Y-FITTING AND TUBING INVOLVING THE COULTER LH 750 HEMATOLOGY ANALYZER. THE CUSTOMER HAD ON PROPER PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, A LABORATORY COAT, AND EYE PROTECTION 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. BECKMAN COULTER CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER IN REPLACING THE TUBING, WITH A HOLE, AT THE Y-FITTING AND RESOLVED THE FLUID LEAK ISSUE. THE CUSTOMER HAS AN EXPOSURE CONTROL PLAN AT THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3220 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1