(b)(4).This report was sent on its due date (10 may 2017).However, the report failed the submission via the fda esubmitter gateway (error message: there is a duplicate report).Therefore, the report was re-sent on 25 may 2017.Method: the complaint rt380 evaqua2 adult breathing circuit was received at fph in (b)(4) and underwent a pressure test and was visually inspected.Results: visual inspection revealed a small hole in the breathing circuit next to the patient end connector.The subject breathing circuit performed outside specification during the pressure test.Conclusion: based on our investigation, the inspiratory limb was likely punctured or scratched with a sharp object, most likely caused by opening the box or packing bags with a knife or box cutter.All rt380 adult dual-heated evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The user instructions that accompany the rt380 breathing circuit state: -perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.-set appropriate ventilator alarms.The hospital correctly performed a leak test before patient use as per the user instructions.
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