BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 1053030 · Received May 17, 2008

    Report

    Report Number
    1053030
    Event Type
    Malfunction
    Date Received
    May 17, 2008
    Date of Event
    April 4, 2008
    Report Date
    May 17, 2008
    Manufacturer
    ALARIS MEDICAL SYSTEMS, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS SCHEDULED FOR A CT SCAN. THE RN WAS ADMINISTERING IV CONTRAST WHEN THE IV TUBING EXPANDED AND THE TUBING CRACKED. THE TUBING WAS QUICKLY REPLACED. THERE WAS A MINOR DELAY TO REPLACE THE TUBING. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS TUBING, IV FPA ALARIS MEDICAL SYSTEMS, INC. 2420-0007 *

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR OTHER| OTHER