(b)(4).The device was returned to baxter, and the evaluation is complete.This is an ancillary service event.The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the discovered issue.An internal/external inspection was performed and the device passed.Temperature confirmation testing was performed and the device passed.Rite (returned instrument test evaluation) electrical testing was conducted and the device passed.The device failed volumetric accuracy testing associated with rite functional testing.Test piston foam was installed and the device was able to pass the volumetric accuracy test.Pneumatic system testing found no issues.When the original piston foam was reinstalled, the device failed the volumetric accuracy testing again.The original piston foam was removed and inspection found that the piston foam was deteriorated and the door piston was cracked.The cause of the reported issue was due to the deteriorated piston foam and the cracked door piston.The device was sent for servicing.Should additional relevant information become available, a supplemental report will be submitted.
|