The actual sample was provided for investigation.The dialyzer was tested per procedure, to see if the dialyzer had leaked blood internally and externally.The dialyzer was found to be leaking during testing.The reported condition was verified.The cause was found to be from a gasket that was incorrectly placed inside the header cap of the dialyzer.This is manufacturing related.The dialyzer was also found to be externally leaking blood out of the header cap.The header cap was found to have a small crack, which was determined to be the cause of the leak.This is a storage related issue.A nonconformance has been opened to address this issue.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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