MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND INSPIRE 8 OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number	050714
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H10: sorin group italy manufactures the inspire 8 oxygenator.The incident occurred in boston, massachussets.The involved device has been requested for return to sorin group italy 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 italy received a report related to a possible blood to water leak of an inspire 8 oxygenator.The issue occurred toward the end of the procedure, when it was noticed light pink/red tinge in the water lines.Medical team chose to finish the surgery as it was very light tinged in color and the case was almost complete.There was no patient injury.
Additional Manufacturer Narrative
H11: review of the complaints database revealed no other similar case notified for the batch concerned from the market, neither a concerning trend was detected.Unit was requested back to livanova for functional testing.After decontamination, returned part was visually inspected and no visible sign of damage to the fiber bundle capillaries of the heat exchanger module nor potting anomaly were observed.A subsequent functional test was performed to verify the integrity of the blood compartment.The blood side of the unit was leak-tested to reproduce the communication between blood and water compartments complained by customer.Part was filled with water and gradually pressurized by sealing all the outlet ports, in line with the maximum internal pressure value permitted in blood path (1 bar) as per product specifications.Breakthrough of solution through the gas escape and across the inner fibers of the heat exchanger module and through the water ports was reproduced.Investigation findings confirmed the presence of an open channel between blood and water compartments due to damaged capillaries in the fiber bundle of the oxygenator module.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 without any deviation and no trend has been registered for similar case, it cannot be excluded that fiber bundle capillary manufacturing variability with the contribution of thermal and/or transportation mechanical stress could have led to breakage during use.No adverse trend has been identified for this issue and the risk remains in the acceptable region.
Event or Problem Description
See initial report.

• Brand Name: INSPIRE 8 OXYGENATOR
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): SORIN GROUP ITALY; via statale 12 nord 86; mirandola 41037 ; IT 41037
• Manufacturer Contact: antonella donatiello ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 19070311
• Report Number: 9680841-2024-00010
• Device Sequence Number: 4658851
• Product Code: DTZ
• UDI-Device Identifier: 08033178112369
• UDI-Public: (01)08033178112369(17)261016(10)2310170004(240)050714
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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 Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2025

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 Catalogue Number: 050714
• Device Lot Number: 2310170004
• 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: 03/13/2024
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2023
• 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