(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 circuit revealed that the expiratory tube of a rt380 adult dual heated evaqua2 breathing circuit was degraded.Further testing revealed that the tubing had been exposed to chemicals that induced hydrolysis and degradation.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.The user instructions that accompany the rt380 breathing circuit state: "do not soak, wash, sterilize or reuse this product.Avoid contact with chemicals, cleaning agents or hand sanitizers." "do not use medications containing tyloxapol (such as tacholiquin) as this may damage the tubing and lead to a loss of ventilation pressure." "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.".
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