(b)(4).Method: the three complaint rt380 adult evaqua2 breathing circuit kits were returned to fisher & paykel healthcare (f&p) in (b)(4) for investigation.These devices were visually inspected.Results: during initial reporting of the complaint, it was reported that the nurse may have tried to connect the nebulizer to the wrong position on the rt380 circuit.Visual inspection revealed that the inspiratory limbs of all three units that were returned had the elbow and the patient end connector loose.Conclusion: we were unable to determine conclusively the cause of the reported event.However, based on previous complaints it is possible that the circuits were cleaned and reused which could lead to the reported event.Rt380 breathing circuits are visually inspected and pressure tested for leaks before releasing for distribution.Any breathing circuit which fails any of these tests is discarded.If any faults are detected the whole batch is placed on hold for investigation.The user instructions that accompany the rt380 breathing circuit state the following: check all connections are tight before use.Set appropriate ventilator alarms.Do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers.Reuse may result in transmission of infectious substances, interruption to treatment, serious harm or death.
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