A healthcare facility in (b)(6) reported a rt380 adult dual heated evaqua2 breathing circuit leaked during patient use.The issue was found soon after set up.It was reported that an alarm sounded indicating a circuit leak.The healthcare facility reported that the patient experienced increased heart rate at 120/min and had desaturated from 93mmhg to 74mmhg.In response, the patient was manually ventilated with a bag-valve mask while the circuit was replaced.The location of the air leakage was found to be at the inspiratory tube connection port to the mr290 vented autofeed humdification chamber.It was further noted that blood analysis was checked again half an hour after the reported event, and results were within normal range.No further patient consequences were reported.
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(b)(4).Corrections: further information was received from the healthcare facility after the submission of the initial report.This confirmed that the reported event occurred prior to patient use and there was therefore no patient involvement or consequence.Section a2/b7 - removed as there was no patient involved.Section h6 (health effect codes) - updated to 4582 - no clinical signs, symptoms or conditions, 2645 - no patient involvement.Section b5 - narration corrected based off additional information.Method: the complaint rt380 adult dual heated evaqua2 breathing circuit was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is therefore based on the information and photograph provided by the customer, and our knowledge of the product.Results: visual inspection of the provided photograph identified damage to the inspiratory tube near the elbow connector.Conclusion: without the return of the complaint device, we are unable to determine the cause of the reported event.All rt380 adult evaqua2 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.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." - "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." - "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.".
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