BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION SET

    MDR report key: 1210929 · Received October 23, 2008

    Report

    Report Number
    MW5008744
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    January 21, 2008
    Report Date
    October 22, 2008
    Manufacturer
    ALARIS
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IV PUMP SCREEN STATED RESET. COULD NOT RESET DUE TO FLUID INFILTRATION FROM SPLIT IV TUBING SET AT UPPER CONNECTION. WHEN PUMP DOOR OPENED TO REPLACE TUBING, MEDICATION, (NEOSYNEPHRINE) RAN ALL OVER THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSION SET IV TUBING SET FPA ALARIS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention