There was no patient involvement.Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).The affected device was requested back to the manufacture's site for a detailed investigation.The reported issue could be confirmed but the black screen could not be reproduced during the tests.The root cause could be identified as the contamination of the hms board with dried fluids.According to the investigator, it is likely that the black screen was due to a failure of the hkr board.These parts will be replaced to solve the problem.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.
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