BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT

    MDR report key: 8895855 · Received August 15, 2019

    Report

    Report Number
    9611451-2019-00779
    Event Type
    Injury
    Date Received
    August 15, 2019
    Report Date
    July 16, 2019
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K983112
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). METHOD: THE COMPLAINT DEVICE WAS REQUESTED FROM THE HOSPITAL BUT HAS NOT BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. THE HOSPITAL ANSWERED SOME INITIAL QUESTIONS FROM US. WE HAVE SOUGHT FURTHER INFORMATION REGARDING THE COMPLAINT AND FOLLOWED UP WITH THE HOSPITAL HOWEVER THEY HAVE NOT RESPONDED TO THESE REQUESTS. THEREFORE, OUR INVESTIGATION IS BASED ON THE INFORMATION AND PHOTOGRAPHS PROVIDED BY THE HOSPITAL. RESULTS: THE HOSPITAL REPORTED THAT THE PATIENT HAD BEEN PLACED ON NIV DUE TO RESPIRATORY DISTRESS, AND THAT THE PATIENT WAS BEING TREATED WITH A PHILIPS V60 VENTILATOR, A FISHER & PAYKEL HEALTHCARE RT219 CIRCUIT AND MR850 HUMIDIFIER, AND A PHILIPS AF541 LEAK 1 MASK. IT WAS ALSO REPORTED THAT THE SYSTEM WAS INITIALLY SET UP CORRECTLY BY A RESPIRATORY THERAPIST. AT SOME POINT, THE SYSTEM SETUP WAS CHANGED TO AN INCORRECT SETUP, WHEREBY THE PATIENT'S MASK WAS DISCONNECTED FROM THE PATIENT PORT OF THE CIRCUIT AND THEN CONNECTED TO THE OUTLET OF THE EXHALATION PORT. WE HAVE BEEN INFORMED THAT THE HOSPITAL WAS UNSURE HOW THE MISCONNECTION OCCURRED. THIS INCORRECT SETUP ALLOWED THE PATIENT TO BREATHE SPONTANEOUSLY BUT DID NOT PROVIDE NIV PRESSURE THERAPY. WE UNDERSTAND THAT THE PHILIPS V60 VENTILATOR IS DESIGNED TO ALARM IN THIS SITUATION WITH A "HIGH LEAK" ALARM. THE HOSPITAL STATED THAT APPROPRIATE ALARMS WERE IN PLACE AND THAT THE PATIENT WAS ALSO MONITORED WITH REMOTE PULSE OXIMETRY. THE HOSPITAL WAS UNABLE TO DETERMINE THE LENGTH OF TIME BEFORE STAFF RESPONDED. WHEN ATTENDING TO THE INCORRECT SET UP, THE DECISION WAS MADE TO CHANGE THE THERAPY FROM NIV TO INVASIVE VENTILATION BECAUSE OF THE PATIENT'S HYPERCAPNIA. IT WAS REPORTED THAT THE PATIENT FULLY RECOVERED AND HAS BEEN DISCHARGED. CONCLUSION: BASED ON THE INFORMATION PROVIDED, IT IS MOST LIKELY THAT A USER ERROR OCCURRED RESULTING IN AN INTERRUPTION TO NIV THERAPY. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT219 BI-LEVEL/CPAP BREATHING CIRCUIT INCLUDES A PICTORIAL SHOWING THE INSTRUCTIONS TO CONNECT THE CIRCUIT AND EXHALATION PORT PROPERLY. IT ALSO INCLUDES THE FOLLOWING ATTENTION AND WARNINGS: CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE DO NOT BLOCK OR SEAL THE VENT HOLES ON THE EXHALATION PORT. APPROPRIATE PATIENT MONITORING (E.G. OXYGEN SATURATION) MUST BE USED AT ALL TIMES. FAILURE TO MONITOR THE PATIENT (E.G. IN THE EVENT OF AN INTERRUPTION TO GAS FLOW) MAY RESULT IN SERIOUS HARM OR DEATH. SET APPROPRIATE VENTILATOR ALARMS EXHALATION PORT MUST BE USED WITH A NON-VENTED INTERFACE ON A SINGLE LIMB SYSTEM. FAILURE TO COMPLY MAY LEAD TO PATIENT INHALING EXCESS CARBON DIOXIDE RESULTING IN HYPERCAPNIA.

    Description of Event or Problem · 0

    A HOSPITAL IN FLORIDA REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE RT219 BI-LEVEL/CPAP BREATHING CIRCUIT AS PART OF A NON-INVASIVE VENTILATION (NIV) SYSTEM WAS INCORRECTLY SET-UP. THE PATIENT WAS FOUND WITH THE EXHALATION PORT ATTACHED DIRECTLY TO A PHILIPS RESPIRONICS MASK. WHEN ATTENDING TO THE INCORRECT SET UP, THE DECISION WAS MADE TO CHANGE THE THERAPY FROM NIV TO INVASIVE VENTILATION BECAUSE OF THE PATIENT'S HYPERCAPNIA. IT WAS FURTHER REPORTED THAT THE PATIENT FULLY RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL.

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY ATTEMPTING TO OBTAIN FURTHER INFORMATION FROM THE HOSPITAL TO ASSIST IN THE INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE RT219 BI-LEVEL/CPAP BREATHING CIRCUIT AS PART OF A NON-INVASIVE VENTILATION (NIV) SYSTEM WAS INCORRECTLY SET-UP. THE PATIENT WAS FOUND WITH THE EXHALATION PORT ATTACHED DIRECTLY TO A PHILIPS RESPIRONICS MASK. THE PATIENT WAS INTUBATED AS A RESULT. THE PATIENT IS NOW DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689546 BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT219

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention F&P MR850 HUMIDIFIER| F&P MR850 HUMIDIFIER| PHILIPS RESPIRONICS MASK AF541| PHILIPS RESPIRONICS MASK AF541| PHILIPS V60 VENTILATOR| V60 VENTILATOR