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

Catalog Number	25-40-45
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report of an electronic gas blender (egb) which suddenly stopped working during priming and could not operate.Cold start and unplugging/re-plugging of unit's cables did not resolve the issue.Consequently, device was replaced with a new one.There was no patient injury.
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: through follow-up communication, it was learnt that multiple error messages related to a communication issue and a failure of the gas blender were highlighted after review of associated heart-lung machine alarm history, which confirmed the reported issue.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: 50911823
• Report Number: 9611109-2026-90457
• Device Sequence Number: 17475424
• Product Code: DTX
• UDI-Device Identifier: 04033817900696
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101046
• 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): 09/28/2026

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 Catalogue Number: 25-40-45
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/28/2026
• Date Device Manufactured: 11/20/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown