There was no patient involvement.Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).The livanova field service representative who identified the issue informed the customer that the part requires replacement to resolve the issue.However, the customer informed the service representative that they are aware of the issue and have elected not to proceed with replacement at this time.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Evaluated on site by livanova rep.
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