BEUDAMED
    FDA Adverse Event Death Summary report: N

    HUDSON VENTILATOR TUBING SET,LONG LENGTH

    MDR report key: 10441859 · Received August 24, 2020

    Report

    Report Number
    3004365956-2020-00155
    Event Type
    Death
    Date Received
    August 24, 2020
    Date of Event
    July 29, 2020
    Report Date
    July 30, 2020
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THE PATIENT'S CAUSE OF DEATH WAS POSSIBLY RESPIRATORY FAILURE, BUT THERE IS NO DOCUMENTATION RELATED TO OFFICIAL CAUSE OF DEATH. THE USER FACILITY REPORTED THEY DID NOT KNOW WHY THE VENTILATOR TUBING DISCONNECTED, BUT THOUGHT THE CONNECTION WAS LOOSE. THE USER FACILITY ALSO NOTED THE VENTILATORS ARE LOUD AND THE ALARMS CAN BE DIFFICULT TO HEAR. COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE, THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE. IF THE SAMPLE BECOMES AVAILABLE AT A LATER DATE A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN INCIDENT SURROUNDING A BREATHING HOSE COMING OFF A VENTILATOR. THE PATIENT WAS ON A PORTABLE VENTILATOR FOR 13 DAYS WITH HIGH PEAK PRESSURES. WHEN THE PROVIDER WENT INTO THE ROOM, THE TUBING WAS DISCONNECTED FROM THE VENTILATOR. THE PATIENT WAS ON MULTIPLE DRIPS AND COULDN'T BREATHE ON HIS OWN. PATIENT WAS REPORTED TO BE UNDER A 'DO NOT RESUSCITATE' (DNR) ORDER AND THEREFORE NO RESUSCITATION ATTEMPT WAS MADE. THE PATIENT DIED ON (B)(6) 2020. THE CUSTOMER REPORTED THE INSPIRATORY SIDE HOSE IS LOOSE AND PRONE TO COME OFF. PER CUSTOMER, THE HIGH PRESSURE VENTILATION MANY PATIENTS REQUIRE CAN LEAD TO 'POP-OFFS' OF THE VENTILATOR TUBING FROM THE VENTILATOR EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908373 HUDSON VENTILATOR TUBING SET,LONG LENGTH CIRCUIT, BREATHING (W CONNECTO CAI TELEFLEX MEDICAL 74D2000023

    Patients

    Seq Age Sex Outcome Treatment
    1 Death PATIENT ON MULTIPLE DRIPS