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

Model Number	8F PH.I.S.I.O.
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Sorin group italia has received a report that, during the setup of a circuit before initiation of a procedure, communication between the oxygenating chamber and the heat exchange chamber inside the oxygenating module of the inspire 8f was seen.The issue was identified prior to any patient involvement.
Additional Manufacturer Narrative
The issue was identified prior to any patient involvement.Sorin group italia manufactures the inspire 8f hollow fiber oxygenator with integrated arterial filter and hardshell.The incident occurred in massa, italy.The involved device has been requested for return to sorin group italia for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
Verification of production records confirmed the device was released conforming to product specifications.Review of livanova complaints database revealed no other similar event relevant to complained lot.Complained oxygenator was returned to livanova for investigation.Visual inspection of the returned part found no damage or visible problem.The water compartment of the unit was subjected to air leak test by setting the same conditions and parameters applied during the in-process leak test and the complained unit failed the test.The in-process leak test is performed on 100% of the units before their release.The results of the tests are stored into livanova internal database.Verification of the test performed before the release of the complained unit confirmed the unit had previously successfully passed the air leak test.The blood compartment of the unit was subjected to water leak.Part was filled with methylene blue and gradually pressurized at 1 bar (maximum recommended internal pressure value as per inspire ifu).A leak was confirmed and drop of dye solution were identified in the water compartment.Investigation findings confirmed the presence of communication between blood and water compartments likely due to damaged capillary in the distal portion of the fibers of the heat-exchanger.Considering that 100% of the units in production line is subjected to final leak test and that involved unit successfully passed the in-process check and no trend has been registered for similar case, it cannot be excluded that fiber bundle capillary manufacturing variability with contribution of sterilization thermal and/or transportation mechanical stress could have led to breakage during use.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
See initial report.

• Brand Name: INSPIRE 8F 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
• 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: 15812842
• Report Number: 9680841-2022-00050
• Device Sequence Number: 20165648
• Product Code: DTZ
• UDI-Device Identifier: 08033178112383
• UDI-Public: (01)08033178112383(17)250218(10)2202190001(11)220219(240)050716
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K130433
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2023

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: 02/18/2025
• Device Model Number: 8F PH.I.S.I.O.
• Device Catalogue Number: 050716
• Device Lot Number: 2202190001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2022
• Supplement Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2022
• 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
• Patient Sex: Unknown