BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PCA MODULE SET

    MDR report key: 6144861 · Received December 5, 2016

    Report

    Report Number
    6144861
    Event Type
    Malfunction
    Date Received
    December 5, 2016
    Date of Event
    November 1, 2016
    Report Date
    November 17, 2016
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENTS BED WAS WET AND THEN DISCOVERED IT WAS COMING FROM THE IV TUBING, THE LEAK WAS COMING FROM THE PIGTAIL SITE WHERE THE IV FLUID INFUSES. MAINTENANCE IVF NORMAL SALINE AT 125 ML/HOUR. DUE TO THE LEAK THE PATIENT WAS HAVING POOR PAIN CONTROL ISSUES, THE TUBING WAS CHANGED OUT AND NEW TUBING PLACED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796418 ALARIS PCA MODULE SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 303, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR