BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATED BREATHING TUBE AND CHAMBER KIT

    MDR report key: 20083368 · Received August 28, 2024

    Report

    Report Number
    9611451-2024-00624
    Event Type
    Malfunction
    Date Received
    August 28, 2024
    Date of Event
    July 28, 2024
    Report Date
    July 29, 2024
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K162553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PRODUCT BACKGROUND: THE HEATED BREATHING TUBE (HBT) IS A COMPONENT DESIGNED FOR USE WITH THE AIRVO 2 HUMIDIFIER (AIRVO 2), FOR THE DELIVERY OF HUMIDIFIED RESPIRATORY GASES TO PATIENTS, INCLUDING THOSE WHO ARE RECEIVING NASAL HIGH FLOW (NHF) THERAPY. NHF THERAPY IS 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 HBT AS PART OF THE AIRVO 2 SYSTEM CONTAINS A HEATER WIRE ENCAPSULATED IN PLASTIC WHICH ENSURES OPTIMAL TEMPERATURE AND HUMIDIFICATION LEVELS ARE DELIVERED TO THE PATIENT INTERFACE WHILE MINIMIZING THE AMOUNT OF CONDENSATE IN THE TUBE. METHOD: THE SUBJECT HBT AS PART OF THE 900PT561 WAS RECEIVED AT FISHER & PAYKEL HEALTHCARE (F&P) IN NEW ZEALAND FOR INVESTIGATION, WHERE IT WAS RESISTANCE TESTED AND VISUALLY INSPECTED. OUR INVESTIGATION IS THUS BASED ON THE EVALUATION OF THE SUBJECT HBT, THE INFORMATION PROVIDED BY THE CUSTOMER AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: THE RESISTANCE CHECK ON THE HEATER WIRE WAS WITHIN SPECIFICATION. THE VISUAL INSPECTION REVEALED THAT THE HBT WAS MELTED AND A PORTION OF THE MELTED TUBE WAS PRESSED. CONCLUSION: WE ARE UNABLE TO DETERMINE THE EXACT CAUSE OF THE REPORTED EVENT. HOWEVER, IT WAS OBSERVED THAT THE MELTED HBT WAS PRESSED, INDICATING THAT THE SUBJECT HBT WAS POTENTIALLY COVERED BY A MATERIAL OR OBJECT FOR A PROLONGED PERIOD. THE 900PT561 USER INSTRUCTIONS SHOW IN PICTORIAL FORMAT THE CORRECT PLACEMENT OF THE DEVICE AND INCLUDES THE FOLLOWING INFORMATION: - "DO NOT ADD HEAT TO ANY PART OF THE BREATHING TUBE E.G., COVERING WITH A BLANKET, OR HEATING IT IN AN INCUBATOR OR OVERHEAD HEATER FOR A NEONATE, AS THIS COULD RESULT IN SERIOUS INJURY." - "CONNECT BREATHING TUBE CLIP TO PATIENT CLOTHING OR BEDDING." - "NEVER OPERATE THE UNIT IF THE BREATHING TUBE HAS BEEN DAMAGED WITH HOLES, TEARS OR KINKS" - "DO NOT BLOCK THE FLOW OF AIR THROUGH THE UNIT AND BREATHING TUBE." - "DO NOT ALLOW THE BREATHING TUBE TO REMAIN IN DIRECT CONTACT WITH SKIN FOR PROLONGED PERIODS OF TIME." ALL HBTS AS PART OF THE 900PT561 ARE VISUALLY INSPECTED AND UNDERGO FUNCTIONAL TESTS, INCLUDING SOAK AND TEMPERATURE, AND HEATER WIRE RESISTANCE. THE HEATED BREATHING TUBES ARE 100% VISUALLY INSPECTED USING A CAMERA SYSTEM. THE HBTS ARE ALSO TESTED FOR RESISTANCE, CONTINUITY, POLARITY AND PITCH DURING PRODUCTION. ADDITIONALLY, A FUNCTIONAL TEST IS CONDUCTED UNDER LOAD. THE HBT WOULD HAVE MET THE REQUIRED SPECIFICATIONS AT THE TIME OF PRODUCTION. THE AIRVO 2 SYSTEM IS DESIGNED TO COMPLY WITH THE ELECTRICAL SAFETY STANDARD IEC 60601-1: 2005+A1:2012. THE CASE IS COMPOSED OF A FLAME RETARDANT MATERIAL. THE SURFACE TEMPERATURE OF THE HBT, WHEN USED IN ACCORDANCE WITH USER INSTRUCTIONS, IS DESIGNED TO BE WITHIN THE LIMITS SPECIFIED BY ISO 8185 WITH REGARD TO HOT TUBE SURFACE TEMPERATURE NOT EXCEEDING 44° CELSIUS. IT IS AN INHERENT RISK OF HBTS, THAT ADDITIONAL HEAT (ABOVE AMBIENT LEVELS) ADDED TO ANY PART OF THE TUBE VIA AN EXTERNAL SOURCE OR BEING COVERED WITH MATERIAL, MAY LEAD TO THE TUBING BECOMING DAMAGED. TO ADDRESS THIS INHERENT RISK AND AS IS REQUIRED UNDER ISO 80601, THE USER INSTRUCTIONS FOR THE 900PT561 CONTAINS THE WARNING "DO NOT ADD HEAT TO ANY PART OF THE BREATHING TUBE E.G. COVERING WITH A BLANKET, OR HEATING IT IN AN INCUBATOR OR OVERHEAD HEATER FOR A NEONATE, AS THIS COULD RESULT IN SERIOUS INJURY." ADDITIONAL "DO NOT COVER" TAGS ARE ALSO ATTACHED TO ALL HBTS TO ALERT THE USER THAT THE HBT SHOULD NOT BE COVERED. THERE ARE MANY SAFETY FEATURES INCORPORATED INTO THE AIRVO 2 SYSTEM TO PREVENT OVERHEATING AND FIRE. THESE INCLUDE: - THE HEATER WIRES IN THE HBT ARE COMPLETELY INSULATED FROM THE GAS PATH. - THE PCB AT THE [PATIENT] END OF THE HBT IS OVER MOULDED WITH THE THERMOPLASTIC POLYMER POLYPROPYLENE, ENSURING IT IS EXCLUDED FROM THE GAS PATH. - THE AIRVO 2 DEVICE CONTAINS TECHNOLOGY WHICH DETECTS SHORT CIRCUITS AND TRANSIENT CURRENT EVENTS IN THE HBT. WHEN DETECTED, THE AIRVO REMOVES POWER TO THE HBT. THE AIRVO 2 PERFORMS THIS DETECTION AT ANY TIME IT IS TURNED ON AND CONNECTED TO THE HBT. THIS FUNCTIONALITY IS CHECKED BY THE CONTROL SYSTEM EACH TIME THE AIRVO IS POWERED UP, OR WHEN A NEW HBT IS CONNECTED. - AN 'OVER-TEMPERATURE' SENSOR WILL AUTOMATICALLY CUT POWER TO THE MOTOR, HEATER PLATE AND HEATER WIRE IF IT DETECTS ANY OVERHEATING AT THE CHAMBER OR THE PATIENT END OF THE HBT. - THE AIRVO 2 DEVICE IS CONTINUOUSLY CHECKS POWER IN THE HBT AND DISABLES THE HEATER WIRE IF THE MEASURED POWER IS TOO HIGH.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN AUSTRALIA REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE HEATED BREATHING TUBE AS PART OF THE 900PT561 WAS FOUND MELTED DURING USE. THE HEALTHCARE FACILITY REPORTED THAT THE PATIENT DESATURATED TO 90%, AND THE NURSE IMMEDIATELY NOTICED THAT THE SUBJECT HBT HAD MELTED. THE SUBJECT HBT WAS THEN REPLACED. THERE WERE NO FURTHER REPORTED PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1494209 HEATED BREATHING TUBE AND CHAMBER KIT HEATED BREATHING TUBE BTT FISHER & PAYKEL HEALTHCARE LTD 900PT561

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown