BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIFUSE

    MDR report key: 3242248 · Received July 17, 2013

    Report

    Report Number
    3242248
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    July 8, 2013
    Report Date
    July 17, 2013
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TRIFUSE TUBING WAS CONNECTED TO PATIENT'S IR (INTERVENTIONAL RADIOLOGY) PICC WAS DISCOVERED SEVERED AT THE HUB. IT APPEARS TO THE RN TO BE A DEFECTIVE TRIFUSE, AS IF THE ADHESIVE USED TO HOLD THE TUBING IN THE LUER LOCK WAS NOT EFFECTIVE. TPN AND FLUIDS WERE INFUSING ONTO THE BED. IT APPEARS THAT THE BEDSIDE RN CAUGHT THE PROBLEM RATHER QUICKLY AS THE VOLUME OF FLUID ON THE LINENS WAS SMALL. DUE TO THE TIMING OF THE INCIDENT, STAFF DO NOT RECALL WHEN THIS MAY HAVE HAPPENED (AFTER A DRESSING CHANGE OR TUBING CHANGE). THE PICC LINE WAS IN THE PATIENT'S UPPER RIGHT EXTREMITY WITH THE TRIFUSE TUBING ATTACHED TO THE PICC. EVENT NOTED BY STAFF TO BE AN UNUSUAL EVENT. THIS ERROR REACHED THE PATIENT AND REQUIRED MONITORING AND INTERVENTION BUT RESULTED IN NO HARM TO THE PATIENT. THIS DEVICE IS IN A CUSTOM KIT FOR THIS FACILITY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331895 TRIFUSE SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO PICC LINE