BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVI

    MDR report key: 67532 · Received February 4, 1997

    Report

    Report Number
    67532
    Event Type
    Injury
    Date Received
    February 4, 1997
    Date of Event
    December 28, 1996
    Report Date
    January 10, 1997
    Manufacturer
    GRASEBY MEDICAL INC.
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    MORPHINE DRIP SET AT 2CC/HR AT 13:00. PUMP FOUND RUNNING AT 50CC/HR AT 13:55 WHEN FAMILY REPORTED TO RN THAT PT WAS SLEEPY AND QUESTIONED SETTING ON PUMP. PT WAS DROWSY BUT AROUSABLE WITH RESPIRATIONS AT 20. NARCAN ORDERED AND ADMINISTERED. THE PUMP HAD BEEN CHANGED TO THE IV PIGGYBACK RATE, WHICH WAS SET AT 50CC/HR. IT IS UNKNOWN WHO SWITCHED THE RATE FROM PRIMARY TO PIGGYBACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVI 480 INFUSION PUMP FRN GRASEBY MEDICAL INC. 480 *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening| R