Sorin group (b)(4) manufactures the centrifugal pump system cp5.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 customer experienced a problem with the centrifugal pump system cp5 after a firmware upgrade due to changes from the previous software version.There was no report of patient injury.The device was not returned, however sorin group (b)(4) r&d evaluated the software and could confirm the described error.Troubleshooting found the issue to be related to a software bug in the firmware.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.As a correction, change order (b)(4) was made and a new firmware version has been implemented (fen 2015-036).Software was evaluated by sorin r&d.
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