Additional information was added to d9, h3, h4, h6 and h10.H10: the device was received for evaluation.During visual inspection, the tubing was observed separated from the third y-site clearlink in the downstream part.The reported condition was verified.The cause of the condition was due to was improper manual assembly.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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