Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate.The service representative was unable to confirm the reported issue.Visual inspection was performed and no visible defects were observed.A functional test was performed without issue and a temperature check-up on both the patient and cardioplegia tanks found that all temperatures were reached within normal amount of time.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.As the issue could not be reproduced, a root cause was not determined.H3 other text : evaluated on site by livanova rep.
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