Patient information was not provided.(b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that the s5 roller pump displayed an error code during a procedure.There was no report of patient injury.A sorin group field service representative contacted the customer to provide tech support.The customer stated that, after receiving the error message, the pump was switched out and the procedure was continued with no additional problems.During the technical support call, the service representative learned that the issue was caused by an operator error.The involved pump was set as a cardioplegia pump utilizing the dual tubing method in the raceway.The tubing got twisted and resulted in the reported error message.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.No trend was identified for this type of issue.Sorin group (b)(4) will continue to monitor for trends related to this type of issue.Technical support provided via phone.
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