(b)(4).Section d4: lot number: 2100802738 (device manufacture date: 21 jun 2019), 2100855888 (device manufacture date: 17 aug 2019), 2100821981 (device manufacture date: 12 jul 2019).Method: the swivels of six complaint rt265 infant dual heated evaqua2 breathing circuits were returned to fisher & paykel healthcare (f&p) for inspection.Results: visual inspection of devices 1, 2, 3 & 4 revealed that the swivels were returned fully assembled.The pressure tests for these devices confirmed a tight fit of swivel components.Visual inspection of devices 5 and 6 revealed that the swivel elbows and swivel wyes were returned partly disassembled.No damages were observed to any of the swivel components.The swivel elbows and swivel wyes were reassembled.The pressure test for devices 5 and 6 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 rt265 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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