(b)(6).The actual device was not available; however, a photograph of the sample was provided for evaluation.During visual inspection of the provided photographic samples, no evidence of the reported event was observed.The reported condition was not verified.The lines of the set including spikes are provided by one of our internal suppliers.There are control measures in place to identify failure modes of this nature.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 st150 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.
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