Prismaflex st100 set ckt 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 device was not received for evaluation; however, a picture of the impacted set was provided.The visual inspection observe the return line was disconnected from the screwed connector.The reported condition was verified.The cause of the event was due to a manufacturing related issue.Should additional relevant information become available, a supplemental report will be submitted.
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