BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADJUSTABLE COAXIAL TEMNO 1920 BIOPSY SYSTEM

    MDR report key: 1981122 · Received December 30, 2010

    Report

    Report Number
    1981122
    Event Type
    Death
    Date Received
    December 30, 2010
    Date of Event
    December 8, 2010
    Report Date
    December 24, 2010
    Manufacturer
    CAREFUSION
    Product Code
    FCG
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT CAME IN AS OUTPATIENT FOR CT GUIDED LUNG BIOPSY. PT ALERT AND ORIENTED THROUGHOUT MOST OF PROCEDURE. PT RECEIVED FENTANYL AND VERSED FOR PROCEDURAL SEDATION. TOWARDS END OF PROCEDURE, PT SNORING. AT END OF PROCEDURE, CHEST CT SHOWED NO PNEUMOTHORAX. OCCLUSIVE DRESSING PLACED AFTER BIOPSY NEEDLE REMOVED. PT UNAROUSABLE. MD CALLED TO PROCEDURE ROOM. BP DROPPED. PLACED IN TRENDELENBURG POSITION. PT FOAMING AT MOUTH AND POSTURING. HEAD CT TAKEN WHICH SHOWED INTRAVASCULAR CEREBRAL AIR EMBOLISM. PT WENT INTO PEA ARREST AND CPR AND RESUSCITATION STARTED. REVIEW OF CT OF CHEST PERFORMED AT END OF PROCEDURE SHOWED AIR IN THE RIGHT VENTRICLE, AORTA AND PULMONARY ARTERY. FEMORAL ARTERIAL AND VENOUS LINES PLACED IN ATTEMPT TO REMOVE INTRACARDIAC AIR. REPEAT CHEST CT SHOWED NEAR RESOLUTION OF INTRACEREBRAL AND INTRACARDIAC AIR. PT DID NOT REGAIN CONSCIOUSNESS. PT TRANSFERRED TO ICU THEN TO OUTSIDE FACILITY FOR HYPERBARIC OXYGEN TREATMENT. INFORMED BY FAMILY THAT PT DIED TWO DAYS AFTER EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADJUSTABLE COAXIAL TEMNO 1920 BIOPSY SYSTEM BIOPSY SET FCG CAREFUSION ACT 2011 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death