The actual device was not available; however, photographs and video of the sample were provided for evaluation.Visual inspection of the provided pictures did not identify any abnormalities that could have contributed to the reported condition.Visual inspection of the provided video showed reported external a fluid leak, at level of the blood header of the filter.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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