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	Hypoxia (1918)
Date of Event	07/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Sorin group italia received a report of a leakage from an inspire 8f oxygenator.The event occurred after 1 hour and 30 minutes of blood circulation.Reportedly, during procedure patient experienced elevated lactate levels and hypoxemia.Consequently, blood transfusion was conducted, which has been considered an additional medical intervention to preclude a serious injury.
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• 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): Soriin Group Italia; via statale 12 nord, 86; mirandola (mo) 41037 ; IT 41037
• Manufacturer Contact: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 50099526
• Report Number: 9680841-2026-900025
• Device Sequence Number: 18761694
• Product Code: DTZ
• UDI-Device Identifier: 08033178112383
• UDI-Public: (01)08033178112383(17)290426(10)2604270002(11)260427(240)050716
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 07/31/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: INSPIRE 8F STERILE
• Device Lot Number: 2604270002
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2026
• Initial Report FDA Received Date: 07/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2026
• 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