(b)(4).Method: the complaint rt202 adult inspiratory heated breathing circuit was requested, however was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is therefore based on the information provided by the customer and our knowledge of the product.Results: it was reported that the dryline of two rt202 adult inspiratory heated breathing circuits had disconnected from chamber during use.It was reported that the patients experienced desaturation and recovered to a stable condition.Simulation testing was conducted to replicate the set-up described in this complaint and used representative production test specimens.Our testing demonstrated that it was only possible to replicate a dryline disconnection under a specific set of abnormal conditions.These included the humidification chamber to dryline connection was not firmly connected, in combination with the ventilation pressure within the system far exceeding 8 kpa which is the maximum pressure limit specified for the mr290 humidification chamber.One way to replicate the increase in pressure was by fully blocking the nasal cannula prongs of the opt944 optiflow + adult nasal cannula attached to the rt202 adult inspiratory heated breathing circuit.Even with these specific set of abnormal conditions, a dryline disconnection was not able to be achieved consistently.The rt202 adult inspiratory heated breathing circuit dryline and humidification chamber connectors are designed to meet iso 5356-1 specifications.Although the exact date of manufacture of the complaint device was not able to be determined, manufacturing records confirmed that there were no non-conformances related to the specifications of these connectors.Conclusion: based on our testing, we were unable to definitively determine a root cause for the disconnection reported by this customer.However, on the basis of our test results, it would appear possible that during set-up the dryline had not been securely connected to the humidification chamber by the user, and in a scenario where there is excessive pressure within the system, it is possible that the dryline may disconnect.All rt202 adult inspiratory heated breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject adult breathing circuit would have met the required specifications at the time of production.The user instructions that accompany the rt202 adult inspiratory heated breathing circuit include a pictorial showing the instructions to set-up the breathing circuit correctly.It also includes the following: - "maximum operating pressure - 8kpa." - "check all connections are tight before use." - "appropriate patient monitoring (e.G.Oxygen saturation) must be used at all times.Failure to monitor the patient (e.G.In the event of an interruption to gas flow) may result in serious harm or death." - "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient." - "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." - "for use under the supervision of trained medical personnel." in addition, the user instructions which accompany the opt944 optiflow + adult nasal cannula also states the following: - "as appropriate for patient's condition, monitor for any disruptions to patient receiving flow." - "select appropriate size.Prongs must not create a seal in the nares.A clear gap must be visible around each prong." - "do not use with an air entrainer, to prevent loss of therapy." - "failure to use the set-up described above can compromise performance and affect patient safety." - "achievable flow rates may depend on individual patient and/or flow source.".
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