BEUDAMED
    FDA Adverse Event Death Summary report: N

    *

    MDR report key: 88903 · Received May 2, 1997

    Report

    Report Number
    88903
    Event Type
    Death
    Date Received
    May 2, 1997
    Date of Event
    April 25, 1997
    Report Date
    May 1, 1997
    Manufacturer
    *
    Product Code
    LTA
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADMITTED 4/25/97 FOR SAME DAY SURGICAL PROCEDURE, UNDERWENT A HYSTEROSCOPY FOR REDUCTION OF UTERINE FIBROID AND OVARIAN CYST. PT WAS PUT UNDER GENERAL ANESTHESIA AND AT 1300, PROCEDURE BEGAN. INITIALLY, HER BLOOD PRESSURES WERE APPROXIMATELY SYSTOLIC OF 100-110- WITH PULSE IN THE 60'S - 50'S. AT 1530, HER BP DECREASED TO SYSTOLIC OF 80'S. AT 1600, THERE WAS AN ABRUPT DESATURATION AND THE PROCEDURE WAS ENDED. THEY HAD USED 18 (3 LITER) BAGS OF GLYCINE DURING PROCEDURE. IN POSTOP, RECOVERY ROOM, WAS SLOW TO AWAKEN AND CONFUSED. ELECTROLYTES AT THAT TIME CONFIRMED FLUID OVERLOAD AND LASIX WAS ORDERED. THIS CAUSED A DIURESIS. HER SERUM SODIUM WAS THEN FOUND TO BE 85MMOL. SHE WAS MOVED TO ICU AT 0130 ON 4/26/97, PUPILS WERE NOTED TO BE FIXED AND DILATED AND SHE WAS UNRESPONSIVE. CT SCAN SHOWED DIFFUSE CEREBRAL EDEMA. DIAGNOSIS MADE OF HYPONATREMIC ENCEPHALOPATHY WITH PRESUMED CEREBRAL HERNIATION SYNDROME. PT WAS DECLARED CLINICALLY BRAIN DEAD AT 1530 ON 4/30/97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * 1.5% GLYCINE IRRIGATION, USP LTA * * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Death