BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE INFUSION SET

    MDR report key: 4444855 · Received January 21, 2015

    Report

    Report Number
    4444855
    Event Type
    Malfunction
    Date Received
    January 21, 2015
    Date of Event
    January 19, 2015
    Report Date
    January 21, 2015
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    AT THE OUT PATIENT CLINIC, THE NURSE HAD DIFFICULTY ATTEMPTING TO BACKFLUSH NORMAL SALINE FROM THE PRIMARY BAG INTO THE SECONDARY CHEMO TUBING WITH A FILTER. THE NURSE HAD TO USE MANUAL PRESSURE ON THE PRIMARY BAG OTHERWISE IT WOULD NOT BACKFLUSH.======================MANUFACTURER RESPONSE FOR CAREFUSION TUBING FOR ALARIS PUMP, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================CURRENTLY MANUFACTURER IS WORKING WITH SCRIPPS CORPORATE LEADERSHIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48374 SMARTSITE INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 303, INC. * 14106981

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR CHEMOTHERAPY