BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE INFUSION SET

    MDR report key: 3113362 · Received May 8, 2013

    Report

    Report Number
    3113362
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 4, 2013
    Report Date
    May 8, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE IV PUMP WAS ALARMING. THE NURSE PAUSED THE IV FLUID INFUSION TO INVESTIGATE. NURSE PLACED THE PUMP ON HOLD AND WHEN SHE OPENED THE CASSETTE IT WAS NOTED TO BE "BUBBLED" OUT WHILE INSIDE THE IV PUMP. NO PATIENT HARM. THERE HAVE BEEN APPROXIMATELY THREE EVENTS WITH THREE DIFFERENT PATIENTS WITH THIS TYPE OF DEVICE AT THIS FACILITY.======================MANUFACTURER RESPONSE FOR SMARTSITE INFUSION SET WITH CHECK VALVE, 3 NEEDLE-FREE VALVES, VENTED/NONVENTED, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================NO RESPONSE AS OF YET. FILLED OUT CAREFUSION FORM, "REPORT OF BALLOONED/ BULGING SILICONE TUBING ISSUE WITH AN ALARIS IV ADMINISTRATION SET".WHAT WAS THE ORIGINAL INTENDED PROCEDURE?IV FLUID INFUSION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200053 SMARTSITE INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * ALARIS SMARTPUMP