BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3181425 · Received June 17, 2013

    Report

    Report Number
    3181425
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    July 22, 2010
    Report Date
    July 22, 2010
    Manufacturer
    *
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    NURSE (RN) WENT TO HANG INTRALIPIDS THAT WERE STRUNG UP BY PREVIOUS SHIFT RN AND HANGING IDLE ON PUMP, NOT ENGAGED DUE TO ANTIBIOTICS INFUSING AT SHIFT CHANGE ON SAME PUMP. WHEN THIS RN WENT TO ENGAGE SYRINGE IN PUMP, PLUNGER FROM SYRINGE FELL OUT WITH LIPIDS SPILLING OUT OF SYRINGE. THIS HAPPENED TWICE WITH 2 SEPARATE SYRINGES.======================HEALTH PROFESSIONAL'S IMPRESSION.======================OVERFILLING OF SYRINGE.DID THIS EVENT INVOLVE AN ELECTROPHYSIOLOGY PROCEDURE OR AN ATTEMPTED ELECTROPHYSIOLOGY PROCEDURE?NO.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LIPID INFUSION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272967 * SYRINGE FMF * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 4 * NO OTHER THERAPIES| IV INTRALIPIDS