BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE

    MDR report key: 3052158 · Received March 15, 2013

    Report

    Report Number
    3052158
    Event Type
    Malfunction
    Date Received
    March 15, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 15, 2013
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON HEARING THE ALARM ON THE IV PUMP, THE RN OPENED THE CHANNEL DOOR AND NOTED A LARGE "BUBBLE" AT THE TOP OF THE TUBING. THE TUBING AND PUMP WERE BOTH REPLACED AND THE INFUSION WAS CONTINUED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?INTRAVENOUS HEPARIN INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110342 SMARTSITE SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 303, INC. 2419-0007 *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR