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

Model Number	S5 COMPONENT GAS BLENDER
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: a livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue product was requested back to manufacturer for repair.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 report regarding an electronic gas blender, which signaled an alarm indicating a difference between the set oxygen flow value (2.0 liters/min) and the actual measured value (1.3 liters/min).No leaks were identified from the piping.Restarting the unit did not resolve or improve the issue.The issue occurred during set-up.There is no report of patient injury.
Additional Manufacturer Narrative
H11: complaints database review revealed no further similar events since unit¿s installation.No concerning trend was highlighted for reported failure mode.Based on the available information, this kind of malfunction can be caused by: - improper hospital gas supply; - a missed gas blender warm-up phase (user error); - defective gas blender's component (gas mass flow controllers and relative flow sensor).- wearing of the unit due to age (manufacturing date:2018).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.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
Device was sent back to manufacturer: reported event was confirmed.The control flow component was found to be defective; replacement was required.Technical safety inspection (tsi) and functional tests were successfully completed.Based on the gathered additional information, root cause has been assigned to a defective control flow component.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• 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: 23605562
• Report Number: 9611109-2025-90537
• Device Sequence Number: 18636439
• Product Code: DTX
• UDI-Device Identifier: 04033817900696
• UDI-Public: (01)04033817900696(11)180309
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/22/2026

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 COMPONENT 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: 10/21/2025
• Supplement Date Received by Manufacturer: 02/20/2026; 03/24/2026
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 03/19/2026; 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown