(b)(6).The device was evaluated on site.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed which included air bubble testing, prime and simulated run.Air bubble testing passed with no issues found.Prime and simulated run verified the air bubble function with no issues found and no repairs needed.The reported condition was not verified.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.
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