(b)(4).Method: the expiratory limb of the complaint rt265 infant evaqua2 breathing circuit was returned to fisher & paykel healthcare in (b)(4) and was visually inspected.Further information was also sought from the customer but a response was not provided.Results: visual inspection revealed that the proximal connector was cracked and partly detached from the expiratory limb.There was no visible damage noted to the tubing itself.A lot check revealed no other similar complaints for the lot number provided.Conclusion: based on the nature of the observed cracking and previous investigations into this type of failure, the cracking is most likely due to the connectors coming into contact with a cleaning chemical, resulting in environmental stress cracking.All rt265 infant dual-heated evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The hospital reported that the damage occurred after a period of use, which suggests that the complaint circuit became damaged after the product was released for distribution.Our user instructions that accompany the rt265 state 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.- set appropriate ventilator alarms.The user instructions also state the following: - do not soak, wash, sterilize or reuse this product.Avoid contact with chemicals, cleaning agents or hand sanitizers.
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