Additional information: an event history log review was performed which did not show any keystrokes, programming, or use related events that would indicate and/or contribute to the reported event of air in the line of the cassette.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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