BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRACHEOSTOMY PVC - PORTEX TUBES PDT ULTRAPERC

    MDR report key: 8497026 · Received April 9, 2019

    Report

    Report Number
    3012307300-2019-01298
    Event Type
    Death
    Date Received
    April 9, 2019
    Report Date
    March 8, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A PATIENT HAD EXPIRED WHILE A SMITHS MEDICAL TRACHEOSTOMY TUBE WAS IN USE. IT WAS REPORTED THE TRACHEAL TUBE HAD BEEN IN THE PATIENT FOR SIX DAYS AND HAD A DIAGNOSIS OF CHRONIC OBSTRUCTIVE LUNG DISEASE, PNEUMONIA AND RESPIRATORY FAILURE. THERE WERE NO PREVIOUS CHEST-TRAUMA RELATED TO THE ADMISSION DIAGNOSIS. SYMPTOMS LEADING TO THE CONDITION INCLUDE RESPIRATORY DISTRESS, OXYGEN DESATURATION, SUBCUTANEOUS EMPHYSEMA. PERFORMED A THORACOCENTESIS TO THE RIGHT HEMITHORAX ON THE SUSPICION OF A PRESSURE PNEUMOTHORAX. OROTRACHEAL INTUBATION WAS MADE IMPOSSIBLE DUE TO A BIG SUBCUTANEOUS EMPHYSEMA ALSO IN THE UPPER AIRWAYS, THEREFORE NO TRACHEAL TUBE CHANGE OUT OCCURRED. THE MOMENT THE PATIENT'S HEART RHYTHM AND CIRCULATION STOPPED, BASAL CHEST COMPRESSIONS WERE PERFORMED. IT WAS REPORTED THERE WAS NO TIME TO PERFORM SURGERY BEFORE THE PATIENT'S CIRCULATION CEASED. TRACHEAL RUPTURE WAS FOUND POSTMORTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288207 TRACHEOSTOMY PVC - PORTEX TUBES PDT ULTRAPERC TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death