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

Catalog Number	25-40-45
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report of an electronic gas blender (egb) for which an error message was displayed and could not operate properly.The event occurred during priming.There was no patient injury.
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: a loan unit was provided in substitution to involved device.Additionally, the customer reported that the issue occurred a few days after device was returned from a different service activity.A livanova field service engineer (fse) was dispatched on site and the event was not confirmed.The gas blender involved was tested for one day, with different parameters being varied during the evaluation, and no error nor anomaly was observed.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: 50912093
• Report Number: 9611109-2026-90458
• Device Sequence Number: 5393936
• Product Code: DTX
• UDI-Device Identifier: 04033817900696
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: 09/04/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown