BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTIFLOW + ADULT NASAL CANNULA

    MDR report key: 13657269 · Received March 2, 2022

    Report

    Report Number
    9611451-2022-00193
    Event Type
    Death
    Date Received
    March 2, 2022
    Date of Event
    February 19, 2022
    Report Date
    February 21, 2022
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K162553
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FISHER & PAYKEL HEALTHCARE (F&P) IS CURRENTLY IN THE PROCESS OF RETRIEVING FURTHER INFORMATION REGARDING THE REPORTED EVENT AS WELL AS THE SUBJECT DEVICE. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    (B)(4). B5: IN THE INITIAL REPORT, IT WAS STATED THAT THE CIRCUIT WAS FOUND DAMAGED AS WELL. FURTHER INFORMATION RECEIVED FROM THE HEALTHCARE FACILITY CONFIRMED THAT ONLY THE OPT944 NASAL CANNULA WAS FOUND DAMAGED AND NOT THE CIRCUIT. THE OPT944 OPTIFLOW + ADULT NASAL CANNULA IS A NASAL CANNULA PATIENT INTERFACE FOR DELIVERY OF HUMIDIFIED RESPIRATORY GASES, INCLUDING THOSE WHO ARE RECEIVING NASAL HIGH FLOW (NHF) THERAPY. OPTIFLOW + INTERFACES ARE DESIGNED FOR USE WITH THE AIRVO 2 SERIES OF HUMIDIFICATION DEVICES. NHF THERAPY AND THE AIRVO 2 DEVICE ARE INTENDED FOR USE WITH SPONTANEOUSLY BREATHING PATIENTS WHO WOULD BENEFIT FROM RECEIVING HIGH FLOW WARMED AND HUMIDIFIED RESPIRATORY GASES. THE AIRVO 2 DEVICE SHOULD NOT BE USED FOR LIFE SUPPORT PURPOSES, AND APPROPRIATE PATIENT MONITORING MUST BE USED AT ALL TIMES. THE CANNULA CONSISTS OF A LIGHTWEIGHT DELIVERY TUBE CONNECTED TO A RIGID PLASTIC BASE AND SOFT NASAL PRONGS (NASAL INTERFACE). THIS ALLOWS THE DEVICE TO BE LIGHT WEIGHT AND DURABLE. 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 HEALTHCARE FACILITY HAD DISCARDED THE COMPLAINT OPT944 OPTIFLOW + ADULT NASAL CANNULA AND SO IT WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) FOR EVALUATION. THE HEALTHCARE FACILITY PROVIDED PHOTOGRAPHS OF THE SUBJECT OPT944 NASAL CANNULA AND SOME ADDITIONAL INFORMATION UPON REQUEST. AN INVESTIGATION WAS CARRIED OUT BY F&P WHICH WAS BASED ON THE INFORMATION AND PHOTOGRAPHS PROVIDED BY THE HEALTHCARE FACILITY, AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: THE HEALTHCARE FACILITY REPORTED THE FOLLOWING SEQUENCE OF EVENTS: THE COVID-19 PATIENT WAS TRANSFERRED FROM THE INTENSIVE CARE UNIT ON (B)(6) 2022 AND WAS RECEIVING NHF THERAPY VIA THE SUBJECT OPT944 NASAL CANNULA. ON (B)(6) 2022, THE CANNULA TUBING WAS CHECKED AT 16.39 AND OBSERVED TO BE INTACT. AT 18.00, THE PATIENT WAS ASSISTED BY CLINICAL STAFF WITH EATING, AND IT WAS NOTED BY THE HEALTHCARE FACILITY THAT THE PATIENT WAS CONFUSED AND HAD BEEN EXPERIENCING SHORTNESS OF BREATH. AT 18.45, THE PATIENT WAS FOUND DECEASED, THE OPT944 CANNULA WAS NOT ON THE PATIENT'S FACE AND THE TUBING WAS OBSERVED TO BE DAMAGED. THE ATTENDING PHYSICIAN DID NOT INITIATE RESUSCITATION AS THE PATIENT HAD LIMITED TREATMENT OPTIONS. VISUAL INSPECTION OF THE PROVIDED PHOTOGRAPHS REVEALED THAT THE TUBING WAS DAMAGED NEAR THE MANIFOLD. CONCLUSION: OUR INVESTIGATION WAS UNABLE TO DETERMINE THE CAUSE OF THE OBSERVED DAMAGE TO THE OPT944 OPTIFLOW + ADULT NASAL CANNULA. HOWEVER, BASED ON OUR KNOWLEDGE OF THE PRODUCT, THE REPORTED DAMAGE IS LIKELY TO HAVE BEEN CAUSED BY THE TUBING BEING SUBJECTED TO EXCESSIVE FORCE DURING USE. THIS IS SUPPORTED BY THE HEALTHCARE FACILITY'S REPORT THAT THE SUBJECT DEVICE HAD ALREADY BEEN IN USE FOR SIX DAYS WITHOUT ISSUE. THE MEDICAL CAUSE OF DEATH WAS REQUESTED FROM THE HEALTHCARE FACILITY. HOWEVER, THE HEALTHCARE FACILITY DID NOT PROVIDE THIS INFORMATION. IT SHOULD BE NOTED THAT THE ATTENDING PHYSICIAN DID NOT INITIATE RESUSCITATIVE EFFORTS AS THE PATIENT HAD LIMITED TREATMENT OPTIONS. MANUFACTURING CONTROLS FOR THE OPT944 OPTIFLOW + ADULT NASAL CANNULA INCLUDE INSPECTIONS DURING PRODUCTION FOR VISUAL DEFECTS INCLUDING CRACKS, TEARS, INCLUSIONS, DISCOLORATION AND STRETCHING OR DEFORMATION. ANY PRODUCT THAT FAILS THE VISUAL INSPECTION IS DISPOSED OF. THE SUBJECT OPT944 OPTIFLOW + ADULT NASAL CANNULA WOULD HAVE MET THE REQUIRED SPECIFICATIONS. THE USER INSTRUCTIONS WHICH ACCOMPANY THE OPT944 OPTIFLOW + ADULT NASAL CANNULA SHOW IN PICTORIAL FORMAT THE CORRECT PLACEMENT AND FITTING OF THE CANNULA, INCLUDING ENSURING THE HEADSTRAP CLIP AND THE TUBING CLIP ARE APPROPRIATELY ATTACHED. THE USER INSTRUCTIONS ALSO WARN: "ENSURE HEAD STRAP CLIP IS ATTACHED, TO PREVENT CANNULA FROM BEING PULLED OUT OF THE NARES." "CANNULA CAN BECOME UNATTACHED IF NOT USED WITH THE HEAD STRAP CLIP." "ATTACH TUBING CLIP TO CLOTHING/BEDDING TO PREVENT CANNULA FROM PULLING OFF FACE." "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." "FAILURE TO USE THE SET-UP DESCRIBED ABOVE CAN COMPROMISE PERFORMANCE AND AFFECT PATIENT SAFETY.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT AN OPT944 OPTIFLOW + ADULT NASAL CANNULA WAS FOUND TO NOT BE ON A COVID-19 PATIENT'S FACE AND THAT THE TUBING WAS DAMAGED. IT WAS REPORTED THAT THE CIRCUIT WAS FOUND DAMAGED AS WELL. THE HEALTHCARE FACILITY FURTHER REPORTED THAT THE PATIENT DECEASED AND RESUSCITATION WAS NOT PERFORMED AS THE PATIENT HAD LIMITED TREATMENT OPTIONS. FURTHER INFORMATION HAS BEEN REQUESTED REGARDING THE REPORTED EVENT AND THE MEDICAL CAUSE OF DEATH.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN FINLAND REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT AN OPT944 OPTIFLOW + ADULT NASAL CANNULA WAS FOUND REMOVED FROM A COVID-19 PATIENT'S FACE AND THAT THE TUBING WAS DAMAGED. THE HEALTHCARE FACILITY FURTHER REPORTED THAT THE PATIENT WAS RECEIVING MORPHINE, WAS CONFUSED AND EXPERIENCING SHORTNESS OF BREATH. THE HEALTHCARE FACILITY FURTHER REPORTED THAT THE PATIENT DECEASED AND RESUSCITATION WAS NOT PERFORMED AS THE PATIENT HAD LIMITED TREATMENT OPTIONS. THE MEDICAL CAUSE OF DEATH WAS REQUESTED FROM THE HEALTHCARE FACILITY. HOWEVER, THE HEALTHCARE FACILITY DID NOT PROVIDE THIS INFORMATION DESPITE SEVERAL ATTEMPTS TO REQUEST THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1337875 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.