(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).On (b)(6) 2017, fse arrived at the site to address the reported event.Fse inspected the device for air in the lines, then replaced the buffer filter for bag #2, and performed a drain flush.No air was noted.Fse was subsequently able to run controls and thirty patient samples with no further issues.No further action was required by field service.The most probable cause of the reported event was due to clogged eluent buffer #2.
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On (b)(6) 2017, the customer reported low pressure errors with their g8 analyzer.The customer attempted to troubleshoot by bleeding the system of air with the waste valve pump running.The customer further reported that the buffer bags were 100%, 80%, and 50% full, respectively.Additionally, when solenoid valve 2 was opened, device pressure dropped to zero, but solenoid valves 1 & 3 maintained pressure.On (b)(6) 2017 field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting hba1c patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.
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