BEUDAMED
    FDA Adverse Event Death Summary report: N

    *

    MDR report key: 132438 · Received November 13, 1997

    Report

    Report Number
    132438
    Event Type
    Death
    Date Received
    November 13, 1997
    Date of Event
    November 5, 1997
    Report Date
    November 11, 1997
    Manufacturer
    VALLEYLAB INCORPORATED PFIZER HOSP PROD GRP
    Product Code
    LMS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ARGON BEAM COAGULATOR WAS USED FOR A LIVER RESECTION. PRIOR TO THE START OF THE CASE, THEY OBSERVED THAT ONE TANK WAS LOW. THEY INSTALLED A NEW TANK. UNIT DID NOT FUNCTION DURING THE CASE. IT WAS OBSERVED THAT THE OUTPUT HAD AN ADDITIONAL FILTER INSTALLED. THIS EXTRA FILTER WAS REMOVED BUT THE UNIT WOULD STILL NOT COAGULATE. POWER WAS TURNED UP WITH NO SUCCESS. NURSE SUPERVISOR NOTICED THAT THE NEW TANK THAT WAS INSTALLED WAS NITROGEN, NOT ARGON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * ARGON BEAM COAGULATION SYSTEM LMS VALLEYLAB INCORPORATED PFIZER HOSP PROD GRP FORCE GSU-22 *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death