BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 1930944 · Received December 17, 2010

    Report

    Report Number
    1061932-2010-00289
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 17, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FLUID LEAK ORIGINATED FROM TUBING IN SAMPLE ACCESS MODULE WHICH CONTAINS BLOOD AND REAGENTS. A BCI FIELD SERVICE ENGINEER REPLACED CUT TUBING IN SAMPLE ACCESS MODULE. THE ROOT CAUSE FOR THIS EVENT WAS CUT TUBING IN THE SAMPLE ACCESS MODULE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO A BLOODY FLUID LEAK IN THE DILUTER PORTION OF COULTER LH 780 HEMATOLOGY ANALYZER. THE FLUID WAS CONTAINED WITHIN THE INSTRUMENT, AND THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT AT THE TIME OF THE EVENT. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. THE FACILITY HAS AN EXPOSURE CONTROL PLAN IN PLACE. MSDS WAS NOT REVIEWED. THERE WAS NO DEATH OR INJURY ASSOCIATED WITH THIS EVENT. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANE OR OPEN LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 780 HEMATOLOGY ANALYZER HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. LH780 NA

    Patients

    Seq Age Sex Outcome Treatment
    1