Device history record was reviewed but nothing linked to the reported event was observed.Device log history was reviewed on the reported date: 15 august.On 15 august at 12:27, infusion is started @ 33 ml/h with a vtbi of 100 ml.At 13:20, a first alarm (not an error) of downstream occlusion is triggered.Pressure limit set @ 400 mmhg at starting, and increased @ 600 mmhg after 2 occlusions alarms at 13:32.During all the afternoon, a total of 10 downstream occlusion alarms are recorded.Pressure limit is decreased at 300 mmhg at 15:17.End of infusion alert (vtbi of 100 + 100 ml reached) is done at 20:47.After, infusion continues during all the night with same flow rate and events of regular occlusions.Note: after each occlusion alarm, a re-start of infusion is mandatory on the pump by user.Therefore, history data could not confirm events described in complaint because the pump has triggered a lot of occlusion alarms to alert an overpressure on downstream side and cannot confirm events described in complaint.The reported device was returned to france for further investigation.The visual check of the pump was compliant.Several tests: pressure accuracy - occlusion alarm accuracy- accuracy flow rate measurement : were performed.All results were compliant with ifu values specifications.The reported event could not be reproduced.No cause can be identified compared to the complaint because all performance tests linked to complaint are compliant compared to our ifu specifications and there's no dysfunction of the pump.This complaint is considered as not valid.For this issue as per our local procedure, we initiated no action.
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