BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 2223350 · Received August 11, 2011

    Report

    Report Number
    2223350
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 30, 2011
    Report Date
    August 11, 2011
    Manufacturer
    ALARIS
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RN ENTERED PATIENT ROOM AND NOTED AIR IN SMALL INCREMENTS IN IV TUBING, ALTHOUGH PUMP WAS NOT ALARMING. SHE REPLACED THE PUMP AND ALL TUBING. THE PATIENT DID NOT APPEAR TO BE HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS INFUSION PUMP FRN ALARIS 10011274 *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR