BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS INFUSION MODULE

    MDR report key: 6069045 · Received November 1, 2016

    Report

    Report Number
    6069045
    Event Type
    Malfunction
    Date Received
    November 1, 2016
    Date of Event
    June 2, 2016
    Report Date
    October 10, 2016
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE RUBBER PART OF THE IV TUBING THAT GOES INTO THE CHANNEL OF THE IV PUMP, RIPPED APART FROM THE SLIDE CLAMP CAUSING MEDICATION TO SPRAY OUT OF THE CHANNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720249 ALARIS INFUSION MODULE IV CHANNEL & IV TUBING FRN CAREFUSION 303, INC. 8100 16045710

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR