There was no patient involvement.Sorin group (b)(4) manufactures the sorin heater-cooler system 3t.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that the sorin heater-cooler system 3t displayed several unknown error codes during the disinfection cleaning process and the pumps stopped working.There was no patient involvement, as this issue occurred during maintenance.A sorin group field service representative was dispatched to the facility to investigate.The unit was run and functional checks were performed.The issue could not be duplicated.A technical safety inspection was performed and the unit was put back into use.This complaint was forwarded to the supplier ((b)(4)), who confirmed that the reported issues are related to the same root cause.However, without knowing which error codes appeared, a root cause could not be determined.A review of the dhr did not identify any deviations or non-conformities relevant to the reported failure.As the issue could not be confirmed, a root cause was not determined and no corrective actions were identified.Sorin group (b)(4) will continue to monitor for trends related to this type of issue.Evaluated on site by sorin service rep.
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