(b)(4).This report is being submitted as the result of a retrospective review conducted in capa (b)(4).A getinge field service engineer (fse) evaluated the iabp unit and was able to reproduce the reported issue.To fix the reported issue, the fse replaced all blood contaminated parts purge valve assembly,iabp (0104-00-0026), assy, safety disk, english (0997-00-0985-01), assy crm english (0997-00-0986-01), and tubing, blood detect, iabp (0008-00-0312).The unit passed all tests per service manual.The fse returned the unit to customer and it is cleared for clinical use.
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