MAUDE Adverse Event Report: SORIN GROUP ITALIA INSPIRE 8F PHISIO OXY MODULE WITH INTEGRATED PHISIO ARTERIAL FILTER; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	8F PH.I.S.I.O.
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Codes	Inflammation (1932); Hematuria (2558)
Date of Event	06/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 e2016005, 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.
Event or Problem Description
Sorin group (b)(4) received a report that the transmembrane pressure of the inspire 8f dual hollow fiber oxygenator increased during a procedure.The user was able to decrease the pressure slightly by increasing the blood temperature from 34°c to 37°c.After the procedure, the patient reportedly experienced haematuria and stronger than normal systemic inflammatory response syndrome.During follow-up information sorin has been informed that there is no report of patient injury.
Additional Manufacturer Narrative
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.

• Brand Name: INSPIRE 8F PHISIO OXY MODULE WITH INTEGRATED PHISIO ARTERIAL FILTER
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola, modena 41037 ; IT 41037
• MDR Report Key: 7684656
• Report Number: 9680841-2018-00020
• Device Sequence Number: 10933717
• Product Code: DTZ
• UDI-Device Identifier: 08033178112383
• UDI-Public: (01)08033178112383(17)210124(10)1801250134
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K130433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/24/2021
• Device Model Number: 8F PH.I.S.I.O.
• Device Catalogue Number: 050716
• Device Lot Number: 1801250134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/16/2018
• Device Age: 6 MO
• Initial Date Received by Manufacturer: 06/16/2018
• Supplement Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 07/13/2018
• Supplement Report FDA Received Date: 08/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR