MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	8 DUAL PH.I.S.I.O.
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	10/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On 21 october 2021, sorin group (b)(6) has received a report that, a customer noticed the presence of foam in the arterial line of an ispire oxygenator.There was no report of any patient injury.On 28 october 2021, sorin group (b)(6) has received a report the customer submitted to italian ministry of health and was informed that air was found also in the cannula.The medical team elected to re-cannulate the patient and the cec time was prolonged.On 16 november 2021, sorin group (b)(6) has been informed the patient has died.
Additional Manufacturer Narrative
Patient information were not provided.Sorin group italia manufactures the inspire 8 dual.The incident occurred in varese, italy.Follow up clarification with the customer are on-going.The involved device has been requested for return to sorin group italia for investigation.According to additional information provided during follow-up activity with pharmaco-vigilance department of hospital, livanova learned that: there was no delayed surgical time.Pump sheet has been made available.Air/foam was noticed inside arterial line after aortic declamping during aortic contropulsator insertion.Debubbling phase was successfully carried out when priming the circuit.Death of patient was reported.No emptying of the reservoir was observed/conducted.Unit is available for return and testing.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.: device not yet received.
Additional Manufacturer Narrative
The oxygenator and the circuit were returned to livanova for investigation and have been gamma-ray decontaminated as per livanova internal procedure on blood contaminated goods.Visual inspection of the circuit and the oxygenator after the decontamination found all components of the circuit were integer without any damage.In fact, the circuit was returned as closed circuit and no leak/fluid was found outside the closed circuit thus indicating all components of the circuit did not allow fluid to leak.The oxygenator was found still full of blood.No obvious problem, damage or misassembly of the oxygenator was visible.To investigate if the oxygenator was integer, the device has been assembled into a circuit and functionally tested.During the simulation, no leak was observed thus indicating all parts of the oxygenator was physically intact and conforming.A full review of manufacturing data (dhr) of the devices indicates that all the in-process controls have been passed.The devices have been released conforming to products specifications.Review of the livanova complaint database, did not identify any other similar event relevant to the lot of the oxygenator, nor circuits items.Based on all the above, no device (circuit and/or oxygenator) could be reproduced, livanova devices behaved as expected.As per additional information, air was observed in the line close to the end of the procedure (after declamping).Since no malfunction was reported in the previous steps, livanova assumes that all components of the circuit behaved as expected till the issue was identified.It shall be noticed that oxygenator and components of the circuits are passive device and thus no modification can occur automatically.Livanova does not have any evidence nor result that can explain how air was suddenly observed into a circuit that was laboratorially shown to be integer and confirmed to have been debubbled correctly.Since no device malfunction could be confirmed, no corrective action is deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
See initial report.

• Brand Name: INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola, modena
• Manufacturer (Section G): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola 41037 ; IT 41037
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 12868339
• Report Number: 9680841-2021-00032
• Device Sequence Number: 12268253
• Product Code: DTZ
• UDI-Device Identifier: 08033178112406
• UDI-Public: (01)08033178112406(17)240802(10)2108040002(11)210804(240)050718
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K121229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 03/03/2022

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: 08/02/2024
• Device Model Number: 8 DUAL PH.I.S.I.O.
• Device Catalogue Number: 050718
• Device Lot Number: 2108040002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2021
• Supplement Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 03/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 65 YR
• Patient Sex: Unknown