(b)(4).Method: the complaint rt265 infant dual heated evaqua2 breathing circuit was returned to fisher & paykel healthcare for evaluation.Results: visual inspection of the returned complaint device revealed that the swivel elbow and swivel wye was returned disassembled.Damage was observed to the swivel wye of the complaint device.The swivel elbow and swivel wye were reassembled and the pressure test confirmed a tight fit of swivel components.Conclusion: investigation into this complaint reviewed the manufacturing process (operator, equipment, measurement and environment), process documentation, samples of product, complaint devices and performed a material analysis.The investigation indicated a potential resin material mix-up was the most likely cause.We have since implemented an additional material verification step, at the point of resin material addition to the moulding machine feed.This verification would identify any potential resin material mix-up prior to use.All rt265 dual-heated evaqua2 breathing circuits are designed to conform to iso:5367.All rt265 circuits are visually inspected, pressure and flow tested during production and those that fail, are rejected.The user instructions that accompany the rt266 infant dual heated evaqua2 breathing circuit also 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.".
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