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

Model Number	S5 ELCTRNC GAS BLENDER 5 LPM
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H.11 livanova deutschland manufactures the electronic gas blender, the event occurred in australia.Through follow up communication with the perfusionist, it was learned that the gas blender lines remained connected throughout the procedure and it functioned correctly until the team attempted to exit the cockpit screen.It was confirmed that the fault occurred only once.A basic functional check has been performed as part of the technical activities and device is currently in use without any reported issues.Serial read out files (real time device parameters and setting recording file) have been collected for analysis.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 that the essenz cockpit showed the error gas blender defective (e1000).The issue occurred during procedure.There is no report of any patient injury.
Additional Manufacturer Narrative
H11.A review of the device¿s service history confirmed that no similar events have been communicated to livanova since the date of manufacturing.A review of complaints database did not identify any trends associated with this type of fault.Following the investigation, the root cause could not be conclusively determined.However, the possibility that the event resulted from a temporary and isolated malfunction of the gas blender cannot be excluded.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
See initial 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 ; arvada, CO
• MDR Report Key: 23376795
• Report Number: 9611109-2025-90466
• Device Sequence Number: 8870904
• Product Code: DTX
• UDI-Device Identifier: 04033817900696
• UDI-Public: (01)04033817900696(11)240820
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 01/14/2026

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 ELCTRNC GAS BLENDER 5 LPM
• Device Catalogue Number: 25-28-68
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 01/14/2026
• Date Device Manufactured: 08/20/2024
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown