(b)(4).Method: the complaint rt380 adult dual heated evaqua2 breathing circuit was returned to fisher & paykel healthcare (f&p) in new zealand, where it was visually inspected and analysed.Results: visual inspection of the returned rt380 adult dual heated evaqua2 breathing circuit identified degradation to the expiratory limb.Further analysis revealed that the tube was exposed to chemicals.Conclusion: we are unable to determine the cause of the reported event.However, based on our investigation, it was most likely due to chemical exposure to the expiratory limb.All rt380 adult dual-heated evaqua2 breathing circuits are visually inspected, and pressure and flow tested during production, and those that fail are rejected.The subject breathing circuit would have met the required specifications at the time of production.Our user instructions that accompany the rt380 adult evaqua2 breathing circuit show in pictorial format the correct set-up of the circuit and also states the following: - "check all connections are tight before use." - "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." - "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient." - "do not soak, wash or sterilize this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers.".
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