MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE 8 PHISIO OXY MODULE WITH INTEGRATED PHISIO HARD SHELL VENOUS DUAL CHAMBE; HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR

Model Number	8 DUAL PH.I.S.I.O.
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 8 phisio oxy module with integrated phisio hard shell venous dual chamber reservoir.The incident occurred in (b)(6).Per exemption number e2016005.The involved device has been received at 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) has received a report of increased inspire 8 trans-membrane pressure at the beginning of a procedure.The medical team elected to change-out the oxygenator.During follow-up information with the customer, on march 04th 2019, sorin group (b)(4) has been informed that lidocaine was administered to the patient during the procedure as a consequence of the increased trans-membrane pressure.There is no report of any patient injury.
Additional Manufacturer Narrative
Sorin group italia manufactures the inspire 8 phisio oxy module with integrated phisio hard shell venous dual chamber reservoir.The incident occurred in treviso, italy.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 oxygenator has been returned to the manufacturer and submitted to gamma ray decontamination prior the inspection.The visual inspection found no defects nor non-conformities.The device was submitted to test for transmembrane pressure verification: the test could not reproduce the claimed issue, the pressure drop values measured during our laboratory test was found to be within product specifications and the device behaved as expected.Based on the evidence of device inspection and on previous investigated similar cases, it can be confirmed that the increase of pressure drop has been associated with platelet adhesion and fibrin layer deposition inside the oxygenator.The most probable root cause of platelet adhesion and fibrin deposition is multi-factorial and include clinical procedure (e.G surgical material), therapies (e.G.Anticoagulant prescription, heparin composition and priming composition) and patient specific health conditions.Based on medical literature, the origin of the activation and interaction appear to be multi-factorial in nature and not device specific.For this reason, no specific corrective action has been identified at the present date.
Event or Problem Description
See intial report.

• Brand Name: INSPIRE 8 PHISIO OXY MODULE WITH INTEGRATED PHISIO HARD SHELL VENOUS DUAL CHAMBE
• Common Device Name: HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola, modena
• MDR Report Key: 8473265
• Report Number: 9680841-2019-00016
• Device Sequence Number: 11076019
• Product Code: DTZ
• UDI-Device Identifier: 08033178112406
• UDI-Public: (01)08033178112406(17)200322(10)1703240006
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K121229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/22/2020
• Device Model Number: 8 DUAL PH.I.S.I.O.
• Device Catalogue Number: 050718
• Device Lot Number: 1703240006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/04/2019
• Device Age: 13 MO
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 06/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1