MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH ELECTRONIC GAS BLENDER 10 L/MIN; 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	05/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H11: livanova deutschland manufactures the electronic gas blender 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 has received a report that, during service, the electronic gas blender displayed alarm e19 (calibration fault, a fault has occurred in the actual value/actual value comparison.Sensor actual value).There was no patient involvement.
Event or Problem Description
See intial report.
Additional Manufacturer Narrative
The electronic gas blender was returned to manufacturer: the reported event was reproduced.The device was recalibrated, which resolved the problem.After performing all the functional tests with positive results, the product was returned to the customer in its expected functions.No concerning trend was highlighted for this failure mode.Based on the investigation findings, it is reasonable to conclude that the reported error was due to the device being out of calibration.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 10 L/MIN
• Common Device Name: GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 22666498
• Report Number: 9611109-2025-90280
• Device Sequence Number: 20706854
• Product Code: DTX
• UDI-Device Identifier: 04033817900696
• UDI-Public: (01)04033817900696(11)230303
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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
• 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: 07/01/2025
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2023
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown