MAUDE Adverse Event Report: SORIN GROUP ITALIA INSPIRE OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	INSPIRE 8F STERILE
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: through follow-up communication, livanova learned that the total blood loss volume was approximately 80 ml, and the blood bag administration was conducted due to the drop in patient hematocrit levels.Livanova initiated an 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 italia received a report of an inspire 8f oxygenator fiber leakage.Subsequently, a reddish foam was released, with consequent blood loss.Bone wax was applied to involved area to minimize blood loss.The patient hematocrit dropped, and a transfusion of one unit of packed red blood cells was performed.Fio2 of 60% and gas flow were adjusted.Surgery was concluded without any further issue.The submission of blood was considered an additional medical intervention to preclude serious injury.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H11: reportedly, during setup, the oxygenator was correctly connected to the support, without any visible signs of damage.During priming, no leak was detected within the circuit or the oxygenator (both blood side and water side).Part was not available for investigation.Exhaustive photographic documentation of the issue was provided.The images and video clearly show blood dripping from the open slot located below the water ports at the bottom housing of the device.These observations are consistent with a physical rupture of the oxygenator fiber bundle.Review for dhrs of both oxygenator finished product and oxygenator module assembled onto it did not identify any deviation related to the reported event: 100% of the units undergo a final leak test during production and the involved unit successfully passed the in-process check.Complaints database review revealed no further similar events for impacted lot.No concerning trend was highlighted for reported failure mode.Based on investigation findings, the reported event was traced back to the presence of a damaged capillary in the fiber bundle of the oxygenator module.In this circumstance, fluid enters the ruptured capillary and leaks out of the gas escape compartment following the gas flow direction.Likely, fiber bundle capillary manufacturing variability and the contribution of thermal and/or transportation mechanical stress led to the component breakage during use.Reported blood transfusion was administered due to patient's drop in hematocrit and independently from the minor blood loss experienced due to device failure.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: INSPIRE OXYGENATOR
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA; via statale 12 nord, 86; mirandola (mo) 41037 ; IT 41037
• Manufacturer (Section G): SORIN GROUP ITALIA; via statale 12 nord, 86; mirandola 41037 ; IT 41037
• Manufacturer Contact: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 23886901
• Report Number: 9680841-2025-900042
• Device Sequence Number: 21245262
• Product Code: DTZ
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2026

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 Model Number: INSPIRE 8F STERILE
• Device Catalogue Number: 050716
• Device Lot Number: 2509240089
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown