BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 587901 · Received March 7, 2005

    Report

    Report Number
    587901
    Event Type
    Malfunction
    Date Received
    March 7, 2005
    Date of Event
    February 2, 2005
    Report Date
    March 7, 2005
    Manufacturer
    ALARIS MEDICAL SYSTEMS INC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS NPO, NOTHING BY MOUTH, AND REQUIRING IV FLUIDS. IV FLUIDS WERE HANGING ON PATIENT VIA ALARIS IV TUBING. RN NOTICED TUBING LEAK. NO FURTHER INFORMATION PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR