The actual device was not available; however, a video and photographs of the sample were provided for evaluation.The returned photographs and video were reviewed, and it was noted that there was a leak from the returned line and the return line was perforated near the screwed connector.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.Prismaflex st150 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.
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