BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTIFLOW + ADULT NASAL CANNULA

    MDR report key: 12659978 · Received October 19, 2021

    Report

    Report Number
    9611451-2021-01193
    Event Type
    Death
    Date Received
    October 19, 2021
    Report Date
    September 20, 2021
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K162553
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PRODUCT BACKGROUND: THE OPT944 OPTIFLOW + ADULT NASAL CANNULA IS AN INTERFACE USED TO DELIVER HUMIDIFIED OXYGEN TO PATIENTS AND CONSISTS OF A LIGHTWEIGHT DELIVERY TUBE CONNECTED TO A RIGID PLASTIC BASE AND SOFT NASAL PRONGS (NASAL INTERFACE). THE INTERFACE IS HELD IN PLACE BY A HEAD STRAP AND FEATURES A HEAD STRAP CLIP WHICH WORKS IN TANDEM WITH THE TUBING CLIP (ATTACHES TO THE PATIENT'S CLOTHING/BEDDING) TO SUPPORT THE WEIGHT OF THE CIRCUIT AND PREVENT THE CANNULA BEING DISLODGED. METHOD: THE COMPLAINT OPT944 OPTIFLOW + ADULT NASAL CANNULA WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) FOR EVALUATION AS IT WAS USED ON A COVID-19 PATIENT. FURTHER INFORMATION WAS REQUESTED FROM THE HEALTHCARE FACILITY, OUR INVESTIGATION IS THUS BASED ON THE INFORMATION PROVIDED BY THE HEALTHCARE FACILITY AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: THE HEALTHCARE FACILITY REPORTED THAT THE PATIENT WAS POSITIVE WITH COVID-19. THE HEALTHCARE FACILITY REPORTED THE FOLLOWING SEQUENCE OF EVENTS: A PATIENT DESATURATED TO BELOW 70% SPO2 AFTER THE TUBING OF THE OPT944 OPTIFLOW + ADULT NASAL CANNULA BROKE AT THE POINT WHERE IT CONNECTS TO THE 3-WAY CONNECTOR. THE HEALTHCARE FACILITY CONFIRMED THAT THE PATIENT WAS SELF-PRONING FREQUENTLY AND IT IS LIKELY THAT THE TUBING WAS PULLED BY THE PATIENT. THE PATIENT EXPERIENCED CARDIO-RESPIRATORY ARREST AND WAS ADMINISTERED CARDIO-PULMONARY RESUSCITATION FOR APPROXIMATELY 30 MINUTES AND LATER DECEASED. IT WAS NOTED THAT THE MEDICAL CAUSE OF DEATH WAS COMPLICATIONS DUE TO COVID-19. CONCLUSION: WITHOUT THE COMPLAINT DEVICE, WE WERE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT. HOWEVER, BASED ON THE INFORMATION PROVIDED BY THE HEALTHCARE FACILITY, THE DAMAGE WAS LIKELY CAUSED BY THE TUBING BEING PULLED. THE HEALTHCARE FACILITY NOTED THAT THE MEDICAL CAUSE OF DEATH OF THE PATIENT WAS DUE TO COMPLICATIONS FROM COVID-19. ALL OPTIFLOW INTERFACES ARE INSPECTED DURING PRODUCTION FOR VISUAL DEFECTS INCLUDING CRACKS, TEARS, INCLUSIONS, DISCOLORATION AND STRETCHING OR DEFORMATION. ANY PRODUCT THAT FAILS THE VISUAL INSPECTION IS DISPOSED OF OR REPROCESSED. THE SUBJECT OPT944 OPTIFLOW + ADULT NASAL CANNULA WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. THE USER INSTRUCTIONS WHICH ACCOMPANY THE OPT944 OPTIFLOW + ADULT NASAL CANNULA SHOW IN PICTORIAL FORMAT THE CORRECT PLACEMENT AND FITTING OF THE CANNULA AND STATES: "APPROPRIATE PATIENT MONITORING MUST BE USED AT ALL TIMES. FAILURE TO MONITOR THE PATIENT MAY RESULT IN LOSS OF THERAPY, SERIOUS INJURY OR DEATH." "DO NOT CRUSH OR STRETCH TUBE, TO PREVENT LOSS OF THERAPY." "ATTACH TUBING CLIP TO CLOTHING/BEDDING TO PREVENT CANNULA FROM PULLING OFF FACE." "FAILURE TO USE THE SET-UP DESCRIBED ABOVE CAN COMPROMISE PERFORMANCE AND AFFECT PATIENT SAFETY."

    Description of Event or Problem · 0

    ON 20 SEPTEMBER 2021, A HEALTHCARE FACILITY IN CANADA REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE TUBING OF AN OPT944 OPTIFLOW + ADULT NASAL CANNULA BROKE DURING USE ON A COVID-19 PATIENT AND THE PATIENT DESATURATED TO BELOW 70% SPO2. THE HEALTHCARE FACILITY FURTHER REPORTED THAT THE PATIENT WAS SELF-PRONING FREQUENTLY AND IT IS LIKELY THAT THE TUBING WAS PULLED BY THE PATIENT. FURTHER INFORMATION RECEIVED ON 1 OCTOBER 2021 INDICATED THAT THE PATIENT EXPERIENCED CARDIO-RESPIRATORY ARREST AND WAS ADMINISTERED CARDIO-PULMONARY RESUSCITATION. IT WAS NOTED THAT AFTER APPROXIMATELY 30 MINUTES OF BEING ADMINISTERED CARDIO-PULMONARY RESUSCITATION, THE PATIENT DECEASED. THE HEALTHCARE FACILITY FURTHER REPORTED THAT THE MEDICAL CAUSE OF DEATH WAS COMPLICATIONS DUE TO COVID-19.

    Additional Manufacturer Narrative · 1

    (B)(4). FISHER & PAYKEL HEALTHCARE ARE CURRENTLY IN THE PROCESS OF RETRIEVING FURTHER INFORMATION REGARDING THIS COMPLAINT. WE WILL PROVIDE A FOLLOW UP REPORT UPON THE COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2021, A HEALTHCARE FACILITY IN (B)(4) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE TUBING OF AN OPT944 OPTIFLOW + ADULT NASAL CANNULA BROKE DURING USE ON A COVID-19 PATIENT AND THE PATIENT DESATURATED TO BELOW 70% SPO2. THE HEALTHCARE FACILITY FURTHER REPORTED THAT THE PATIENT WAS SELF-PRONING FREQUENTLY AND IT IS LIKELY THAT THE TUBING WAS PULLED BY THE PATIENT. FURTHER INFORMATION RECEIVED ON (B)(6) 2021 INDICATED THAT THE PATIENT EXPERIENCED CARDIO-RESPIRATORY ARREST AND WAS ADMINISTERED CARDIO-PULMONARY RESUSCITATION. IT WAS NOTED THAT THE PATIENT LATER DECEASED. FURTHER INFORMATION HAS BEEN REQUESTED REGARDING THE SEQUENCE OF EVENTS AND THE MEDICAL CAUSE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1555820 OPTIFLOW + ADULT NASAL CANNULA BTT BTT FISHER & PAYKEL HEALTHCARE LTD OPT944 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death F&P 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT| F&P 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT| F&P PT101 AIRVO 2 HUMIDIFIER| F&P PT101 AIRVO 2 HUMIDIFIER| F&P 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT| F&P PT101 AIRVO 2 HUMIDIFIER