Livanova (b)(4) manufactures the s3 roller pump.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).Through follow-up communication, livanova (b)(4) was informed that the customer does not plan to repair the s3 roller pump.The customer plans to discard the s3 device and purchase a new s5 unit.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Customer does not want repair.
|