Additional narrative: this report is being submitted due to a retrospective review conducted under capa (b)(4).(b)(4).Device evaluation by manufacturer: the field service engineer (fse) was dispatched on (b)(6) 2016.The fse replaced the purge and uptake check valves for the pump.The engineer also replaced the pump diaphram, injector valve stator face and rotor seal.Patient sample was run, flow rate adjusted.Precision was ran along with calibrators and controls the fse also upgraded the software to version 5.23.The g8 was working as intended.No further action required by fse.The probable cause of the event was a clogged stator face.
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