MAUDE Adverse Event Report: SORIN GROUP ITALIA - S.R.L. INSPIRE 6F; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	INSPIRE 6F STERILE
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1-a5 patient information was not provided.H11: sorin group italia manufactures the inspire 6f, the event occurred in india.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 that, at the beginning of the procedure, the reservoir of an inspire 6f oxygenator was blocked and it was decided to change the whole cardioplegia circuit.There is no report of any patient injury.

• Brand Name: INSPIRE 6F
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA - S.R.L.; 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: 24162695
• Report Number: 9680841-2026-900003
• Device Sequence Number: 13103607
• Product Code: DTZ
• UDI-Device Identifier: 08033178112376
• UDI-Public: (01)08033178112376(17)280309(10)2503110002(11)250311(240)050715
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K130209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2026

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 Catalogue Number: 050715
• Device Lot Number: 2503110002
• 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: 12/24/2025
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 06/24/2026
• Date Device Manufactured: 03/11/2025
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown