MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	8F PH.I.S.I.O.
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	Death (1802)
Date of Event	07/22/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Patient information were not provided.Sorin group (b)(4) manufactures the inspire 8f hollow fiber oxygenator with integrated arterial filter and hardshell.The incident occurred in (b)(6).The involved device is not available for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Sorin group (b)(4) has received a report that, 30 minutes after the begin of the procedure, the values of the transmembrane pressure of the inspire oxygenator were high.The medical team elected to change out the oxygenator.After the change out, the values of the transmembrane pressure back to normal.Livanova has been informed the patient has died on the same date (b)(6) 2020).The medical team does not believe there is any correlation between the event and patient demise.
Additional Manufacturer Narrative
The pump-sheet of the case was not provided, however, during follow-up activity, it was pointed out that blood coagulation had developed in the system.The biological deposits reasonably caused the partial occlusion of filtering elements thus reducing the open surface for blood flow and leading to increase of the pressure drop across the oxygenator.No further similar complaints were recorded for noticed product lot.Manufacturing records were verified to be conforming to specifications.According to historical data analysis, the high transmembrane oxygenator pressure gradient is related to the increase of hydraulic resistance as a result of undesired cellular activation associated with platelet adhesion and fibrin layer deposition inside the oxygenator.This type of event is a multi-factorial phenomenon possibly triggered by a combination of clinical procedure, therapies (e.G.Anticoagulant prescription, heparin composition and priming composition) and patient-specific health conditions.Based on collected evidences, the claimed high pressure excursion was confirmed and assigned to reported activation of clotting phenomenon throughout the circuit.No specific action was currently deemed necessary.Livanova maintains and documents periodic customer events monitoring process in order to evaluate actions for products improvement.The likelihood of occurrence of complained failure is acceptable.Livanova will keep monitoring the market.

• Brand Name: INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola, modena
• MDR Report Key: 10391318
• Report Number: 9680841-2020-00014
• Device Sequence Number: 11679860
• Product Code: DTZ
• UDI-Device Identifier: 08033178112383
• UDI-Public: (01)08033178112383(17)220402(10)1904030009
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K180448
• 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): 07/23/2020

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: 04/02/2022
• Device Model Number: 8F PH.I.S.I.O.
• Device Catalogue Number: 050716
• Device Lot Number: 1904030009
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 08/11/2020
• Supplement Report FDA Received Date: 11/20/2020
• 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: Death
• Patient Age: 63 YR