The actual device was not available; however, a photograph and video of the sample were provided for evaluation.During visual inspection of the provided video, the return line was observed to be perforated and leaking fluid.The reported condition was verified.The cause of the condition was not determined as no further or actual sample testing could be performed.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.Prismaflex st100 set c has been temporarily approved for use in the us under emergency use authorization eua (b)(4) to deliver crrt to treat patients in an acute care environment during the covid-19 pandemic.
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