BEUDAMED
    FDA Adverse Event Death Summary report: N

    GEMSTAR PAIN MANAGEMENT

    MDR report key: 613431 · Received June 10, 2005

    Report

    Report Number
    2921482-2005-00329
    Event Type
    Death
    Date Received
    June 10, 2005
    Date of Event
    May 14, 2005
    Report Date
    May 17, 2005
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    "PATIENT WAS ATTACHED TO PUMP WITH MORPHINE TAKEN THE NEXT DAY, THE FOLLOWING DAY. THE PUMP WAS PROGRAMMED IN PAIN MANAGEMENT MODE, BOLUS ONLY DELIVERY IN MG, CONCENTRATION 1 MG/ML, NO LOADING DOSE, BOLUS DOSE 1 MG, BOLUS LOCKOUT 5 MINUTES, NO DOSE LIMIT SELECTED, CONTAINER SIZE 100MG IN 100ML, AND AIR ALARM ON. IN 05/2005 AT AN UNSPECIFIED TIME, THE DELIVERY WAS INITIATED,. THE NEXT DAY AT 4:00PM, THE DELIVERY WAS DISCONTINUED. THE PATIENT WAS REPORTED TO HAVE, "PIN POINT PUPILS AND APPEARED TO BE MORPHINE INTOXICATED." THE PATIENT CONTROLLED ANALGESIA (PCA) OBSERVATION CHART INDICATED BETWEEN 05/2005 AT 1150 AND THE NEXT DAY 1530, THE PATIENT RECEIVED 78 MG OF MORPHINE AND THE MORPHIEN WAS WITHIN THE PHYSICIAN PRESCRIBED PARAMETERS. REPORTEDLY ONE DAY LATER AT 6:05PM, THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMSTAR PAIN MANAGEMENT INFUSION PUMP FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death