Ps324644 section d4 lot number.Device 1 and 2: unknown; device 3 - 13: lot number 2100799293 section h4 manufacturing date of device 3 - 13: (b)(6)2019 method: the complaint rt266 infant dual heated evaqua2 breathing circuits were returned to fisher & paykel healthcare for evaluation.Results: visual inspection of the returned complaint devices revealed that the swivel elbow and swivel wye were returned either partly disassembled or fully disassembled.The swivel wyes of complaint devices 2, 3, 4, 5, 6, 8, 9, 11,12, 13 were found damaged.No damages were observed to the swivel components of complaint devices 1, 7, 10.The swivel elbows and swivel wyes were reassembled.The pressure test for the complaint devices 1, 3, 5, 8, 9 confirmed a loose fit of swivel components and the pressure test for the complaint devices 2, 4, 6, 7, 10, 11, 12, 13 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 infant dual-heated evaqua2 breathing circuits are designed to conform to iso:5367.All 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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