BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION SMART SITE INFUSION SET

    MDR report key: 3842533 · Received May 27, 2014

    Report

    Report Number
    3842533
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 27, 2014
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE NURSE HAD PLACED THE IV TUBING INTO THE IV PUMP AND THE TUBING BUBBLED UP LIKE A BALLOON. THE TUBING HAD NOT BEEN FLUSHED. WHEN THE STAFF OPENED THE DOOR OF THE PUMP IT WAS READING CHANNEL ERROR. THE STAFF CHANGED THE TUBING. THIS HAS RECENTLY OCCURRED ON THREE OTHER OCCASIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310974 CAREFUSION SMART SITE INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION * 14036020

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR ALARIS IV PUMP