MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND ESSENZ; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	CONSOLE PLUS
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that the essenz hlm cockpit had exited automatically from the selected profile.The issue occurred during procedure.There is no report of any patient injury.
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova deutschland manufactures the essenz hlm system.The event occurred in italy.Livanova has 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
See initial report.
Additional Manufacturer Narrative
H11.Complaints database review revealed that similar events have been reported by other customers.Notably, throughout the reboot event , the pumps continued to operate fully, and the system remained controllable through the backup control unit with no impact on the clinical procedure.Reboot is an intended mitigation to reestablish the user interface in case of an unrecoverable exception at the tscp board level.This causes the linux operating system to reset the application to resolve the problem.By design, during the reboot, the heart-lung machine's critical functions, including pumps, alarms, sensors, and safety systems, continue to perform as expected.During the reboot, the cockpit screen shows the livanova logo and once the cockpit user interface is restored, the ¿last case¿ button enables users to retrieve all prior settings and proceed without any data loss.Livanova initiated an improvement action in order to further decrease the already low frequency of occurrence of this type of event.The risk is low and in the acceptable region.Livanova will keep monitoring the market.

• Brand Name: ESSENZ
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, 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: 23770484
• Report Number: 9611109-2025-90589
• Device Sequence Number: 13197389
• Product Code: DTQ
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K232291
• 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): 04/09/2026

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: CONSOLE PLUS
• Device Catalogue Number: 49-00-10
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 04/09/2026
• Date Device Manufactured: 10/06/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown