MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE OXYGENATOR 6F; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	INSPIRE 6F STERILE
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H.11.Livanova manufactures the inspire 6f hollow fiber oxygenator.According to information, the patient was already anesthetized, there was no harm to the patient.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 has received a report that, at the time of starting the valve replacement surgery, a leak in the luer connection of the arterial line of the inspire oxygenator was observed.Medical team elected to change out the oxygenator.There was no report of any patient injury.
Additional Manufacturer Narrative
H11: no information was provided regarding surgical phase of the oxygenator replacement nor on the product changeout duration.Complaints database review revealed no similar events for impacted product lot.No concerning trend was detected for reported failure mode.Based on the available information and on the review of similar events, the most likely root cause of the event was traced back to an inadequate tightening of male luer lock connector of the sampling line by the user.Product instruction for use recommends to verify all connections and secure them prior to starting the procedure in this regard.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 OXYGENATOR 6F
• 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: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 21974700
• Report Number: 9680841-2025-900006
• Device Sequence Number: 7265054
• Product Code: DTZ
• UDI-Device Identifier: 08033178112376
• UDI-Public: (01)08033178112376(17)270719(10)2407190257(11)240719(240)050715
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K130209
• 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): 02/23/2026

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 6F STERILE
• Device Lot Number: 2407190257
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2024
• 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