BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE INFUSION SET

    MDR report key: 4557674 · Received February 25, 2015

    Report

    Report Number
    4557674
    Event Type
    Malfunction
    Date Received
    February 25, 2015
    Date of Event
    February 14, 2015
    Report Date
    February 25, 2015
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    IV MEDICATION, ZOSYN, WAS HUND FOR INFUSION. A COUPLE OF HOURS LATER, THE NURSE NOTED THAT THE BAG OF ZOSYN WAS EMPTY AND THE CHAMBER OF THE PRIMARY TUBING WAS FULL. THE ZOSYN APPEARED TO HAVE BACK FLOWED INTO THE PRIMARY TUBING. THERE WAS NO HARM TO THE PATIENT. PLEASE NOTE: THIS IS THE SAME ISSUE REPORTED MULTPLE TIMES.======================MANUFACTURER RESPONSE FOR SMARTSITE INFUSION SET, CAREFUSION SMARTSITE INFUSION SET (PER SITE REPORTER).======================THIS HAS BEEN AN ONGOING ISSUE. HOSPITAL CORPORATE RISK MANAGEMENT HAS BEEN WORKING WITH THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134024 SMARTSITE INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 303, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR