MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND ELECTRONIC GAS BLENDER; GAS CONTROL UNIT, CARDIOPULMONARY BYPASS

Model Number	S5 ELECTRONIC GAS BLENDER 10L
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H11: 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
Livanova deutschland received a report of an electronic gas blender which displayed error message onto display (e19, "calibration fault").The event occurred during regular maintenance.There was no patient involvement.

• 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: 23543976
• Report Number: 9611109-2025-90525
• Device Sequence Number: 9448975
• Product Code: DTX
• UDI-Device Identifier: 04033817900696
• UDI-Public: (01)04033817900696(11)190813
• 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,Followup
• Report Date (Section B): 05/08/2026

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: S5 ELECTRONIC GAS BLENDER 10L
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 05/08/2026
• Date Device Manufactured: 08/13/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown