(b)(6).The actual device was not available; however, a video and photograph of the sample were provided for evaluation.The returned video and photograph were reviewed, and it was noted that there was a leak at the level of the return screwed connector.The reported condition was verified.The cause of the reported condition could not be determined.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.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 eua (b)(4) with a specific indication to treat patients with covid-19 infection.
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