A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in largo, florida.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue: stirrer mechanism was completely seized and not turning at all.To fix the issue, stirrer motor and erosion kit were replaced.Subsequent functional verification testing was completed without further issues and the unit was returned to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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