Corrected information a1, b5, h6: b5: there was no patient involvement.No additional information is available.H6: medical device problem code a070908 is corrected to a160106.Health effect - impact code f26 is updated to f27.Additional information d9, h3, h6 and h10: the device was received for evaluation.Functional testing was performed and did not identify any issues related to the customer reported condition.The device was found to pass upstream and downstream occlusion testing.Flow rate testing was also performed, and the flow rate of the device was found to be within specification.A service history review was performed and revealed that the device has no previous service events; therefore, servicing did not cause or contribute to the reported event.The reported conditions "not infusing" and 'failed both occlusion tests' were not verified.Should additional relevant information become available, a supplemental report will be submitted.
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