(b)(6).Prismaflex st100 set c has been temporarily approved for use in the us under emergency use authorization (b)(4) to deliver crrt to treat patients in an acute care environment during the covid-19 pandemic.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The actual device was not available; however, a photograph of the sample was provided for evaluation.The visual inspection of the provided picture showed a fluid leak at the level of the male luer lock of a cracked access line.The cause of the reported issue was design related.A nonconformance has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.
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