Additional information: h3, h6, h11.H11: the actual device was not available; however, photographs of the sample were provided for evaluation.Visual inspection of the photos showed that the effluent pump segment was disconnected from the support plate.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The reported condition was verified.The cause of the tubing disconnection was determined to be related to manufacturing.A previous nonconformance and a corrective action preventive action record were opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.
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