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 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) 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 (b)(4).Software was evaluated by sorin (b)(4).
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