As a minor injury was reported by the customer, this report has been classified as an adverse event.However, the reported injury was not serious.(b)(6).The age of the device was calculated as the time elapsed between device sterilization and the date of the event.(b)(4).Sorin group (b)(4) manufactures the inspire 8f phisio oxy module with integrated phisio arterial filter.The incident occurred in (b)(6).Per exemption number (b)(4), sorin group (b)(4).Is submitting the report for both sorin group (b)(4) (manufacturer) and (b)(4).The involved device has been requested for return to sorin group (b)(4) for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not yet returned.
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Sorin group italia manufactures the inspire 8f phisio oxygenator module.The incident occurred in zurich, switzerland.Per exemption number e2016005, sorin group italia s.R.L.Is submitting the report for both sorin group italia s.R.L (manufacturer) and livanova usa., inc.(importer).The involved device was returned to sorin group italia for investigation.Visual inspection of the device did not identify any visible defects.To evaluate the pressure drop under standard conditions, simulated use testing was performed.No device malfunction was identified during this testing.The device was found to be conforming to the manufacturer specifications.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.As the issue was not reproduced, a root cause was not determined.However, based on the evidence from previously investigated cases, sorin group italia believes a likely root cause of the increased pressure drop to be platelet adhesion and fibrin layer deposition inside the oxygenator.The most probable root cause of platelet adhesion and fibrin deposition is multi-factorial and includes the clinical procedure (e.G surgical material), therapies (e.G.Anticoagulant prescription, heparin composition and priming composition) and patient specific health conditions.The event does not appears to be device-specific.Sorin group italia will keep monitoring the market for similar events.
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