BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGO

    MDR report key: 4173637 · Received August 19, 2014

    Report

    Report Number
    4173637
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 18, 2014
    Manufacturer
    MEDRAD INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US

    Narratives

    Description of Event or Problem · 1

    AN INFUSION OF FLUORODEOXYGLUCOSE (F18-FDG) IN PREPARATION FOR A CT/PET SCAN APPEARED TO OCCUR WITHOUT ANY INDICATION OF PROBLEMS. THE INFUSION SYSTEM RECORDED THE DELIVERY AS SUCCESSFUL. THE SCAN, HOWEVER, DID NOT INDICATE THE PRESENCE OF THE ISOTOPE. A SUBSEQUENT EXAMINATION OF THE INFUSION SYSTEM REVEALED THAT PART OF THE DELIVERY CIRCUIT TUBING HAD BECOME PARTIALLY DISPLACED FROM THE PINCH VALVE THAT CONTROLS FLOW THROUGH IT, RESULTING IN THE FDG BEING DELIVERED TO THE WASTE BAG INSTEAD OF THE PATIENT.======================MANUFACTURER RESPONSE FOR PET INFUSION SYSTEM, INTEGO (PER SITE REPORTER).======================THE MANUFACTURER IS AWARE OF THE PROBLEM AND INDICATED THAT THEY EXPECT TO BE MAKING A MODIFICATION EARLY NEXT YEAR IN AN ATTEMPT TO RESOLVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498389 INTEGO PUMP, INFUSION FRN MEDRAD INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *