BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE

    MDR report key: 2926429 · Received January 18, 2013

    Report

    Report Number
    2926429
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 18, 2013
    Manufacturer
    CARE FUSION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    PACU RN WAS REMOVING TUBING FROM IV PUMP PREPARING PATIENT FOR TRANSFER TO FLOOR AND FOUND THE PART OF THE TUBING THAT FITS INTO THE MACHINE HAD AN OUTPOUCHING OF FLUID. BUBBLED AREA APPROX 7/8 OF AN INCH LONG AND 9/16 OF AN INCH WIDE. THE PUMP HAD BEEN INFUSING WITHOUT ISSUE. STAFF REPORT THEY HAVE NEVER SEEN THIS BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27661 SMARTSITE TUBING, FLUID DELIVERY FPA CARE FUSION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR