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

Model Number	10 L/MIN
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report of an error related to co2 mixing of an electronic gas blender (egb).The event occurred during procedure.There was no patient injury.
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
The egb was returned to manufacturer for repair.The error was confirmed and reproduced.The device was repaired and calibrated.After performing all the functional tests with positive results, the unit was released back into regular service.The involved egb was manufactured in 2018 and according to the complaints database review, a similar event was submitted in 2020.No adverse trend was detected concerning this failure mode.Based on investigation findings, the root cause of the event has been traced back to calibration drift of the egb components.The wearing of electro-mechanical devices can be originated by the specific use condition at customer site that may have contributed to the event, such as movements or liquids penetration.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 ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 23433960
• Report Number: 9611109-2025-90490
• Device Sequence Number: 4783116
• Product Code: DTX
• UDI-Device Identifier: 04033817900696
• UDI-Public: (01)04033817900696(11)180604
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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: 10 L/MIN
• 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: 10/03/2025
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown