The company service representative was able to resolve the reported event remotely with the customer.Over the phone, the company service representative performed tests with the client, including priming the cassette.The company service representative concluded that the reflux was working normally, and there was no need for intervention.A system non-conformance based review of the batch/lot/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 lot/batch/serial number was performed.No similar complaints were reported for the product lot/batch/serial under investigation.The system was found to have no problem; therefore, the root cause of the reported event is inconclusive.The 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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