Additional information: the reporter stated that the dialysis machine had presented a flow problem (effluent) alarm at the time of the event.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; however, the machine was reported to have presented a flow alarm.Switched pbp and effluent lines are a known cause of this alarm.The cause of the switched lines was determined to be an assembly issue during the manufacturing process.To address this issue, the involved operator has been retrained and awareness training was provided to all operators.The reported lot was manufactured prior to this action.Should additional relevant information become available, a supplemental report will be submitted.
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