Livanova (b)(4) manufactures the s5 roller pump.The event occurred in (b)(6).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 was able to reproduce the reported issue.The service representative did not identify any signs of liquid ingress into the pump panel or the touch screen and the surface of the touch screen was not externally damaged.The display, pcb hkr0325, ribbon cable 6 pole, speaker cable, ribbon cable 33 pole, and the pump joint parts were replaced.Subsequent functional verification did not identify further issues.A photograph of the replaced touch screen was sent to livanova (b)(4) for evaluation and it was determined that there in fact were signs of fluid ingress.This is a known issue for which a capa (b)(4) has already been implemented.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.
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