BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADULT BREATHING CIRCUIT

    MDR report key: 4886056 · Received July 2, 2015

    Report

    Report Number
    9611451-2015-00298
    Event Type
    Death
    Date Received
    July 2, 2015
    Report Date
    June 5, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K983112
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO DEVICES WERE RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) IN (B)(6) FOR EVALUATION. SAMPLES OF THE EQUIPMENT USED IN THE INCIDENT WERE REQUESTED BUT HAVE NOT BEEN PROVIDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE HOSPITAL: - A TRACHEOSTOMY PATIENT WAS ON AN MR850 SETUP VIA A NON-FPH TRACHE ADAPTOR WITH THE CUFF INFLATED. - A CLOSED SUCTION CATHETER WAS CONNECTED TO THE TRACHE ADAPTOR VIA A T-PIECE CONNECTION - FLOW TO PATIENT WAS SET AT 60 LPM - A RESPIRATORY THERAPIST (NAME NOT PROVIDED) RESPONSIBLE FOR THE SET-UP HAD MADE A MISTAKE IN NOT DEFLATING THE CUFF WHEN USING THE SETUP DESCRIBED ABOVE THE TIME AND DATE OF THE INCIDENT WAS NOT PROVIDED BY THE HOSPITAL. BASED ON THE DESCRIPTION OF EVENTS PROVIDED BY THE HOSPITAL, WE CAN CONCLUDE THAT THE PATIENT WAS UNABLE TO EXPIRE THE VENTILATORY GASES AS THEIR AIRWAY WAS EFFECTIVELY BLOCKED BY THE TRACHE ADAPTOR CUFF. FLOW WOULD HAVE ENTERED THE PATIENT'S LUNGS VIA THE TRACHE INTERFACE BUT WOULD NOT HAVE BEEN ABLE TO ESCAPE DUE TO THE INFLATED CUFF. THERE WAS NO DEFECT REPORTED WITH THE RT202 CIRCUIT, RATHER THE PROBLEM WAS CAUSED BY INAPPROPRIATE USE OF THE NON-FPH TRACHE ADAPTOR WITH THE SUCTION CATHETER. ALL BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THE RT MANAGER HAS ACKNOWLEDGED THAT (B)(6) HOSPITAL-(B)(6) RT STAFF KNOWS THAT FISHER & PAYKEL HEALTHCARE DOES NOT ADVOCATE A CLOSED SUCTION CATHETER IN-LINE WITH A TRACHE ADAPTOR AND THAT THE CUFF SHOULD HAVE BEEN DEFLATED. AT THE REQUEST OF THE RT MANAGER A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE HAS MET WITH HOSPITAL STAFF TO OFFER FURTHER GUIDANCE ON THE CORRECT SETUP FOR TRACHE PATIENTS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT A PATIENT USING AN RT202 ADULT BREATHING CIRCUIT DEVELOPED TENSION PNEUMOTHORAX DURING SUCTIONING AND DIED AFTER HOSPITAL STAFF HAD NOT DEFLATED THE CUFF ON A TRACHE ADAPTOR, THUS BLOCKING THE PATIENT'S AIRWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430720 ADULT BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT202

    Patients

    Seq Age Sex Outcome Treatment
    1 Death FISHER & PAYKEL MR850 HUMIDIFIER