BEUDAMED
    FDA Adverse Event Summary report: N

    MEDFUSION

    MDR report key: 1020403 · Received March 13, 2008

    Report

    Report Number
    1020403
    Date Received
    March 13, 2008
    Date of Event
    August 24, 2006
    Report Date
    March 7, 2008
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FRN
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    POSSIBLE UNDERINFUSION OF IV MEDICATION INDICATED BY PATIENT RESPONSE TO DRUG BEING INFUSED. INFUSION PUMP WAS PROGRAMMED TO DELIVER BODY WEIGHT/CONCENTRATION MODE WHICH IS USED BY ANESTHESIA. NURSING USES VOLUME OVER TIME AND RATE MODE, CAUSING CONFUSION TO NURSE OPERATOR AND POSSIBLY INDUCED PROGRAMMING ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDFUSION PUMP, IV FRN SMITHS MEDICAL 2010 *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY CARDIAC DRUGS| CARDIAC DRUGS