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

Model Number	S5 COMPONENT GAS BLENDER
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that the s5 hlm electronic gas blender showed error 19 during priming.There is no patient involvement.
Additional Manufacturer Narrative
A1-a5 patient information was not provided.H11 livanova field service engineer was dispatched to customer facility, tested the device and could not confirm the issue.Visual inspection revealed no abnormalities.Calibration was carried out and confirmed to be within specifications.Technical safety inspection verified that all safety parameters were met.To ensure reliability, the engineer conducted a 12-hour test run proving that device operated without errors or interruptions.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
See initial.
Additional Manufacturer Narrative
A device service history review has been performed and identified that the unit was manufactured in 2015 and no other similar event has been reported.Considering the results of the service activity, a hardware defect of the egb can be ruled out.Based on the investigation performed for similar cases, the issue was most likely caused by an improper hospital gas supply or an insufficient gas blender warm-up phase.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 GMBH; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 23848141
• Report Number: 9611109-2025-90613
• Device Sequence Number: 9599472
• Product Code: DTX
• UDI-Device Identifier: 04033817900696
• UDI-Public: (01)04033817900696(11)150921
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2026

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
• Device Model Number: S5 COMPONENT GAS BLENDER
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 03/16/2026
• Date Device Manufactured: 09/21/2015
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown