H10: the actual device and pictures were returned for evaluation.The visual inspection of the actual sample by naked eyes showed the product as on the provided photo dry and the blood protection caps was attached on the dialysate port.A torn piece of silicone was found on one blood connection, on the inner cone.The most likely cause of the reported failure is the torn piece of silicone of the arterial line connector, which probably tore off due to over-tightening of the connector and caused the external leakage.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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