The actual device was not available; however, a photograph and a video of the sample were provided for evaluation.The returned photograph and video were reviewed, and it was noted that there was an external leak blood from the access line post pump, near the support plate.The reported condition was verified.The cause of the 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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