(b)(4) is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number (b)(4).This report is being submitted due to a retrospective review conducted under capa(b)(4).On (b)(6) 2017, an fse conducted an onsite follow-up with the customer to address the reported event.During servicing, the fse replaced the injector valve unit and the rheodyne valve.They also found air in the lines at pressure pump and replaced both the pressure and gradient pumps.They ran the patient samples without any issue.The instrument was operational.There was no further action required by fse.The most probable cause of the reported event was due to a bad injector valve and pressure pump.
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On (b)(6) 2017, a customer reported low pressure errors with their g8 analyzer.The customer reported that they were able to correct the low pressures with a drain flush.Technical support advised the customer to check the system for leaking and the tightness of all the connections.The customer was also advised to replace the buffer bag filters and adjust the buffer bag straws.However, the low pressure errors persisted.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting a1c patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.
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