BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1203574 · Received September 25, 2008

    Report

    Report Number
    1203574
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Report Date
    September 24, 2008
    Manufacturer
    ALARIS MEDICAL SYSTEMS, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PIV TO LEFT HAND FOUND TO HAVE AIR IN TUBING. IV TUBING FOUND TO HAVE A SMALL HOLE JUST BELOW THE PUMP AND AIR SEEMED TO BE GETTING INTO THE TUBING AT THAT POINT. MD NOTIFIED. PATIENT MONITORED FOR COMPLICATIONS. NONE NOTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 6 DA