BEUDAMED
    FDA Adverse Event Death Summary report: N

    TEMNO NEEDLE BIOPSY 20GX11CM ADJ COAXIAL

    MDR report key: 1971361 · Received January 27, 2011

    Report

    Report Number
    9680904-2011-00001
    Event Type
    Death
    Date Received
    January 27, 2011
    Date of Event
    December 8, 2010
    Report Date
    January 27, 2011
    Manufacturer
    CAREFUSION
    Product Code
    FCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS AVAILABLE FOR REVIEW, THEREFORE WE ARE UNABLE TO DETERMINE THE EXACT CAUSE FOR THE ISSUE REPORTED. HOWEVER; THE CUSTOMER DID STATE THAT SHE WAS UNAWARE OF ANY PRODUCT ISSUE THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. BASED ON THIS INFORMATION THIS REPORTED ISSUE DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS OR THE DEVICE DESIGN. (B)(4).

    Description of Event or Problem · 1

    PATIENT CAME IN AS OUTPATIENT FOR CT GUIDED LUNG BIOPSY. PATIENT WAS ALERT AND ORIENTED THROUGHOUT MOST OF PROCEDURE. PATIENT RECEIVED FENTANYL AND VERSED FOR PROCEDURAL SEDATION. TOWARDS END OF THE PROCEDURE, PATIENT SNORING AND END OF PROCEDURE CHEST CT SHOWED NO PNEUMOTHORAX. OCCLUSIVE DRESSING PLACED AFTER BIOPSY NEEDLE REMOVED. PATIENT UNAROUSABLE. MD CALLED TO PROCEDURE ROOM. BP DROPPED, PLACED IN TRENDELENBURG POSITION. PATIENT FOAMING AT MOUTH AND POSTURING. HEAD CT TAKEN WHICH SHOWED INTRAVASCULAR CEREBRAL AIR EMBOLISM. PATIENT 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. PATIENT DID NOT REGAIN CONSCIOUSNESS. PT. TRANSFERRED TO ICU AND THEN TO OUTSIDE FACILITY FOR HYPERBARIC OXYGEN TREATMENT. INFORMED BY FAMILY THAT PATIENT DIED TWO DAYS AFTER EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEMNO NEEDLE BIOPSY 20GX11CM ADJ COAXIAL TEMNO NEEDLE BIOPSY 20GX11CM ADJ COAXIAL FCG CAREFUSION ACT2011 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death