MAUDE Adverse Event Report: LivaNova Deutschland Electronic Gas Blender; Gas Control Unit, Cardiopulmonary Bypass

Model Number	Electronic Gas Blender
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H11: through followup communications, it was learnt that event occurred while preparing an hlm system.Unit was returned to manufacturer: technical safety inspection including a prolonged stress test was conducted and device was found to work according to manufacturer specifications.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: Electronic Gas Blender
• Common Device Name: Gas Control Unit, Cardiopulmonary Bypass
• Manufacturer (Section D): LivaNova Deutschland; lindberghstraße 25; munich 80939 ; GM 80939
• Manufacturer (Section G): LivaNova Deutschland; lindberghstraße 25; munich 80939 ; GM 80939
• Manufacturer Contact: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 50565110
• Report Number: 9611109-2026-90407
• Device Sequence Number: 15977020
• Product Code: DTX
• UDI-Device Identifier: 04033817900696
• UDI-Public: (01)04033817900696(11)250620
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K101046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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: Electronic Gas Blender
• Device Catalogue Number: 25-40-45
• 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: 08/07/2026
• Supplement Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/02/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2024
• Patient Sequence Number: 1
• Patient Sex: Unknown