BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 2073590 · Received April 21, 2011

    Report

    Report Number
    2073590
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    March 14, 2011
    Report Date
    April 14, 2011
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE NURSE NOTICED THAT THE IV BAG WAS EMPTY AND WHEN REMOVING IV TUBING FROM PUMP, THE NURSE FOUND THAT AIR HAD TRAVELLED ALL THE WAY PAST THE SECTION OF TUBING THAT PASSES THROUGH THE SENSOR ON THE PUMP. THE PUMP FAILED TO ALARM INDICATING "AIR IN LINE." THE NURSE INSPECTED THE TUBING AND NOTED THAT THE AIR HAD NOT REACHED THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS INFUSION PUMP, MODULE FRN CAREFUSION 8100 *
    2 ALARIS INFUSION PUMP FRN CAREFUSION 8015 *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR