BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 3500

    MDR report key: 1211337 · Received October 13, 2008

    Report

    Report Number
    1211337
    Event Type
    Malfunction
    Date Received
    October 13, 2008
    Date of Event
    October 9, 2008
    Report Date
    October 13, 2008
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    MEDICATION WAS SET TO INFUSE 26 ML OVER 2 HOURS. PUMP DISPLAY SHOWED IT RUNNING AT 13 ML/HR. HOWEVER, MEDICATION RAN FOR 3.5 HOURS. PUMP PROGRAM WAS ENTERED BY RN AND DOUBLE CHECKED BY ANOTHER RN TO CONFIRM PUMP PROGRAMMED CORRECTLY. PUMP REMOVED FROM SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDFUSION 3500 PUMP, SYRINGE FRN SMITHS MEDICAL MEDFUSION 3500 PUMP *

    Patients

    Seq Age Sex Outcome Treatment
    1 23 MO