Initial reporter address:(b)(6).Initial reporter city.Oxiris c is similar to oxiris and oxiris s.Oxiris and oxiris s have been temporarily approved for use in the us under emergency use authorization (b)(4) with a specific indication to treat patients with covid-19 infection.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.During visual inspection of the provided photographic samples, the cone of the access male luer lock (mll) is broken.The reported condition was verified.Due to the nature of the provided sample, no further testing could be performed; therefore, the cause of the condition could not be determined.However, the most probable cause of the leak is likely due to a broken mll cone.These components are provided to the manufacturing plant already assembled by our supplier.A nonconformance has been opened to address this issue.Within in the nonconformance an investigation was performed allowing to identify that this event is due to: the presence of liquid on the mll cone or in the female luer lock (fll) before connection (e.G., use of disinfectant or drop of priming solution, drop of dialysate solution) which lubricates the connection.An improper connection handling (using the body of mll fistula and/or fll components for tightening the connection instead of screwing the coupling nut).Mll design or a combination of these factors can lead to an overtightening of the luer connection which can lead to blocked connection and/or cracks which can cause subsequent leakages.Design change control of the mll ongoing.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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It was reported a oxiris c set leaked due to a loose connection.After approximately five minutes into hemodialysis therapy, the unspecified hemodialysis machine alarmed an unknown air alarm.The nurse observed air bubbles ¿continuously entering the connection of the red end¿.The nurse returned the extracorporeal blood, then disconnected the line.The nurse ¿confirmed that the connection of the red end was not tightly sealed¿.The set was unusable due to a crack in the male lock of the access line and was replaced.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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