There was no patient involvement.Livanova (b)(4) manufactures the s5 double head pump.The incident occurred in (b)(4).This medwatch report is being filed on behalf of livanova (b)(4).A livanova field service representative was dispatched to the facility to investigate.The service representative confirmed the reported issue and identified dirt between the display and the rubber seal of the housing, which could cause the reported issue.The touch screen was replaced and the software was updated.Subsequent testing did not identify further issues and the unit was returned to service.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The replaced parts have been scrapped.No further evaluation can be performed.The root cause is believed to be the penetration of dirt and dust into the device.Replaced device has been scrapped.
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