The company representative was able to confirm (via event log review) but was unable to replicate the reported event.The system was then tested, which met specification.A non-conformance based review of the serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this serial number was performed.A potentially relevant complaint was found and reviewed as part of this investigation.The complaint was opened for the first event that occurred in this reported event, in which the system stopped working after priming.The system was found to functionally exhibit no problems during an onsite assessment.Therefore, the root cause of the reported event is inconclusive.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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