Livanova (b)(4) manufactures the centrifugal pump 5 (cp5).The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate.The service representative reproduced the setup in an attempt to reproduce the fault.However, the fault could not be reproduced.A serial readout of the cp5 was performed.Functional checks were carried out and all modules and devices operated as expected.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Evaluated on site by livanova technician.
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