H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Sample received: samples received consist in seventeen cassette products, the samples were received in new condition with their original packaging in a plastic bag.Visual inspection results: no damage, kinks or any discrepancies that could cause the failure mode reported.Functional testing results: samples were fully priming and connected without difficult, the pump was set running and no alarms were activated.Complaint is not confirmed.The customer stated problem was not duplicated.No actions was taken due complaint was not confirmed.The cause of the reported problem could not be determined.A dhr (device history review) was performed and no problems or issues were identified during this dhr review.
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