A distributor on behalf of a healthcare facility in (b)(6) reported, via a fisher & paykel healthcare (f&p) field representative, that an rt380 adult dual heated evaqua2 breathing circuit was found to have a hole in the inspiratory circuit prior to use on a patient there was no patient involvement.
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(b)(4).Method: the complaint rt380 evaqua 2 adult breathing circuit was returned to fisher & paykel healthcare (f&p) for evaluation, where it was visually inspected and pressure tested.Results: visual inspection of the returned complaint circuit was observed to have a small hole in the inspiratory limb next to the elbow.A pressure test revealed that the breathing circuit was out of specification.Conclusion: based on the appearance and shape of the hole as well as previous investigations, the hole was most likely caused by the user while opening the box or the circuit kit bag with a sharp object like a box cutter.All rt380 adult evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject infant breathing circuits would have met the required specifications at the time of production.Our user instructions that accompany the rt380 adult evaqua2 breathing circuit state the following: 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.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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A distributor on behalf of a healthcare facility in japan reported, via a fisher & paykel healthcare (f&p) field representative, that an rt380 adult dual heated evaqua2 breathing circuit was found to have a hole in the inspiratory circuit prior to use on a patient there was no patient involvement.
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