BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    MDR report key: 383348 · Received March 13, 2002

    Report

    Report Number
    6000001-2002-00209
    Event Type
    Death
    Date Received
    March 13, 2002
    Date of Event
    February 3, 2002
    Report Date
    February 14, 2002
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    A USER FACILITY REPORT WAS RECEIVED REPORTING AN INCIDENT WHERE A TERMINALLY ILL PT RECEIVED AN OVERINFUSION OF MORPHINE. THE PT WAS ORDERED TO RECEIVE 2 MG/HR OF MORPHINE BUT WAS FOUND TO HAVE RECIEVED 100MG OVER 1 HR. NO MEDICAL INTERVENTION WAS PERFORMED. THE FACILITY REPORTED THAT 12 HOURS AFTER THE OVERINFUSION, THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLO-GARD 6201 VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE (SG) 6201 NA

    Patients

    Seq Age Sex Outcome Treatment
    1