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

Model Number	INSPIRE 8
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Oxygenator failed as cpb was initiated.Prebypass o2 checks were all normal.Blender, flowmeter, and oxygen sensor were all registering normal o2 levels.Immediately upon initiation of bypass, perfusionist noticed dark blood with fio2 setting at 100%.Perfusionist traced the gas flow line, no leaks or obstructions were found.Perfusionist called for backup.3 perfusionists troubleshooted and could not find any issues with gas flow to the oxygenator.It was then decided to change out the oxygenator.They came off of cpb for a few minutes while anesthesia ventilated the patient and they changed out the oxygenator.As soon as bypass was re-initiated, bright red blood was observed and new oxygenator was working efficiently.There is no report of any patient injury.
Additional Manufacturer Narrative
A.1.-a.5.No patient information has been provided.D.4.The inspire 8 hollow fiber oxygenator is a non-sterile device assembled into a sterile convenience pack that is distributed in the usa.The expiration date refers to the sterile finished product into which the oxygenator was assembled.The unique identifier (udi) number of the sterile convenience pack is provided.G.5.The involved inspire 8 hollow fiber oxygenator is a non-sterile component assembled into a convenience pack that is distributed in the usa.The standalone oxygenator (catalog number 050701) is also registered in the usa (510(k) number: d335918).H.4.The device manufacture date refers to manufacture date of the sterile, finished convenience pack into which the oxygenator was assembled.H.11.Livanova manufactures the inspire 8 hollow fiber oxygenator.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: INSPIRE 8
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; via statale 12 nord, 86; mirandola (mo) 41037 ; IT 41037
• Manufacturer (Section G): SORIN GROUP ITALIA; via statale 12 nord, 86; mirandola (mo) 41037 ; IT 41037
• Manufacturer Contact: antonella donatiello ; arvada, CO 80004
• MDR Report Key: 22296120
• Report Number: 9680841-2025-900013
• Device Sequence Number: 15567884
• Product Code: DTZ
• UDI-Device Identifier: 00803622133909
• UDI-Public: (01)00803622133909(17)270317(11)250317(240)046006500(10)2507600036
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2026

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 Model Number: INSPIRE 8
• Device Catalogue Number: 03707
• Device Lot Number: 2502130079
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 07/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2025
• 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