BEUDAMED
    FDA Adverse Event Death Summary report: N

    CO2EFFICIENT ENDOSCOPIC INSUFFLATOR

    MDR report key: 1208903 · Received October 16, 2008

    Report

    Report Number
    1450997-2008-00001
    Event Type
    Death
    Date Received
    October 16, 2008
    Date of Event
    September 29, 2008
    Report Date
    October 15, 2008
    Manufacturer
    NORTHGATE TECHNOLOGIES, INC.
    Product Code
    FCX
    PMA / PMN Number
    K053008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE INFORMATION AVAILABLE, THIS PATIENT PRESENTED A PULMONARY EMBOLISM WITH A FATAL OUTCOME. THE OCCURRENCE OF THE PULMONARY EMBOLISM CLOSE TO THE USE OF THE DEVICE IS COINCIDENTAL, AND THE PULMONARY EMBOLISM IS PROBABLY RELATED TO AN HYPERCOAGULATION STATUS OF THE PATIENT PRIOR TO THE PROCEDURE. A CAUSAL RELATIONSHIP BETWEEN THE FATAL EVENT AND THE USE OF THE DEVICE CAN ALMOST CERTAINLY BE EXCLUDED. FURTHER INFORMATION IS REQUIRED FOR CONFIRMATION.

    Description of Event or Problem · 1

    NARRATIVE: A BRACCO ACCOUNT REPRESENTATIVE WHO IS NOT A HEALTHCARE PROFESSIONAL REPORTED: THE BRACCO/EZEM ACCOUNT REPRESENTATIVE WAS REQUESTED TO DEMONSTRATE THE USE OF A CO2EFFICIENT ENDOSCOPIC INSUFFLATOR. A FEMALE PATIENT WAS SCHEDULED FOR AN ENDOSCOPIC ULTRASOUND (EUS) AND THE ACCOUNT REPRESENTATIVE WAS PRESENT TO DEMONSTRATE THE USE OF THE INSUFFLATOR FOR THE PROCEDURE. THE ASSISTANT NURSE MANAGER OF PRE-OPERATIVE SERVICES PROVIDED THE CO2 TANK AND THE CO2 WAS CONNECTED TO THE INSUFFLATOR AND THE CONNECTION CHECKED. THE ACCOUNT REPRESENTATIVE PROVIDED INFORMATION ON SET-UP AND USE OF THE DEVICE. AN OLYMPUS TOWER AND OLYMPUS SCOPE WERE ALSO BEING USED FOR THE PROCEDURE. THE PHYSICIAN ENTERED THE PATIENT'S ESOPHAGUS AND WITHIN 20 TO 25 MINUTES THE PROCEDURE WAS COMPLETED. THE PROCEDURE SEEMED STANDARD COMPARED TO OTHER EUS PROCEDURES THE ACCOUNT REPRESENTATIVE HAD SEEN. THE ACCOUNT REPRESENTATIVE LEFT THE ROOM AND COULD HEAR THE ANESTHESIOLOGIST CALLING THE PATIENT'S NAME TO WAKE HER UP FROM THE ANESTHESIA. AFTER TWO OR THREE MINUTES, THE ACCOUNT REPRESENTATIVE WENT TO THE WAITING ROOM. AFTER 15 MINUTES, THE ACCOUNT REPRESENTATIVE RETURNED AND COULD SEE THROUGH THE DOOR THAT THE PATIENT'S EYELIDS WERE BLUE AND HER SKIN TONE WAS PALE. SHE HEARD SOMEONE ASK FOR THE DEFIBRILLATOR. ABOUT 20 TO 30 MINUTES LATER, A NURSE AT THE OPERATING ROOM DESK TOLD THE ACCOUNT REPRESENTATIVE THE PATIENT DIED. THE ACCOUNT REPRESENTATIVE STATED THAT THE ACCOUNT DID NOT IMPLY AT NO TIME DURING HER VISITS, THAT THE USE OF THE CO2 VIA THE CO2EFFICIENT WAS A CONTRIBUTING FACTOR TO THE DEATH. THE NEXT DAY, A HEALTH PROFESSIONAL, THE ASSISTANT NURSE MANAGER OF PRE-OPERATIVE SERVICES AT THE FACILITY REPORTED: THE NURSE MANAGER REPORTED TO THE BRACCO ACCOUNT REPRESENTATIVE, THE PATIENT HAD JUST STARTED TAKING BIRTH CONTROL PILLS, AND WITH AN HYPERCOAGULATION STATUS PRIOR TO THE PROCEDURE. THE CAUSE OF DEATH WAS PULMONARY EMBOLISM, HER LUNGS WERE BLOCKED, A CODE BLUE WAS CALLED, AND THEY ATTEMPTED TO RESUSCITATE THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CO2EFFICIENT ENDOSCOPIC INSUFFLATOR INSUFFLATOR, CARBON DIOXIDE FOR ENDOSCOPE FCX NORTHGATE TECHNOLOGIES, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Death