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.The actual device was not available; however, a photograph of the sample was provided for evaluation.The returned photographs were reviewed, and it was noted that there was a leak t the level of the connection between the effluent line pre pump and the support plate.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.
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