The patient was placed on extracorporeal membrane oxygenation (ecmo) support on (b)(6) 2018.It was reported that after converting to mains power, a "system alert: s3" alarm occurred on the primary console, and the flow disappeared on the display leaving only "dash" marks.Flow was still visible in the circuit.Initial re-positioning and disconnection/re-connection of flow probe did not resolve the issue.The backup primary console was powered up and the flow probe was connected to circuit.Initially, this showed flow on the display, but quickly disappeared to show the same error code and dash marks for flow.The backup primary console was powered down, left for approximately 20 seconds, re-powered, and the error code resolved.The circuit was moved to the backup primary console without event.Flow was displayed and no repeat of error occurred.No other events occurred.Reportedly, the patient did not suffer any hemodynamic compromise due to the event.No additional information was provided.
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Additional information: device evaluation: the report of an s3 alarm was confirmed through a submitted picture, which showed an s3 alarm active on the primary console.The specific primary console on which this alarm occurred could not be determined from the picture nor could the cause of the alarm.The reported complaint could not be verified nor reproduced during their testing.The primary console was tested with related motor serial number (b)(4) that was returned under the same complaint (refer to medwatch mfr report # 2916596-2018-02272 for the motor).The units were operated multiple times but no error messages were observed.Flow values were displayed consistently.No issues were found.As a result, the root cause of the reported event could not be conclusively determined.Reports of similar events will continue to be tracked and monitored.No further information was provided.The manufacturer is closing the file on this event.
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