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

Model Number	COCKPIT COMPLETT
Medical Device Problem Codes	Application Program Problem (2880); Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1 to a5: there was no patient involvement.H11: livanova deutschland manufactures the essenz console.The incident occurred in canada.Through follow up communication with the customer, it was learned further details regarding the event.At the end of the bypass procedure while the roller pump was recirculating fluid through the oxygenator recirculation line, the cockpit screen became grey/black and home page became available with "last case icon".The perfusionist pressed on it.It looked like it was searching to open the main window and became grey/black and home page became available.This time the "last case" option was no longer available.The perfusionist pressed on their regular profile icon; the patient height, bsa information were no longer available, like starting a new case.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 a report that a cockpit screen of an essenz console became grey and black, loosing visibility of data.The customer was not able to retrieve the last case after the reboot.The system rebooted to the profile selection page.The issue occurred post-procedure.There was no patient involvement.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H11: a livanova field service representative was dispatched to the facility to investigate the device and extracted the cockpit log files.The investigation suggested that the issue was caused by an error of the technician during the machine software flashing.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: the complaints database was reviewed over the past 24 months, covering all installed essenz hlm systems globally.No concerning trends about the reported failure was observed, confirming the isolated nature of the incident.Based on investigation results the root cause was addressed to an isolated human error during the software flashing process.The risk is in the acceptable region.No specific action was currently deemed necessary.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: antonella donatiello ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 22383477
• Report Number: 9611109-2025-90222
• Device Sequence Number: 20998521
• Product Code: DTQ
• UDI-Device Identifier: 04033817903048
• UDI-Public: (01)04033817903048(11)240830
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/10/2026

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: COCKPIT COMPLETT
• Device Catalogue Number: 28-97-10
• 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: 06/05/2025
• Supplement Date Received by Manufacturer: 10/03/2025; 03/10/2026
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 10/31/2025; 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2024
• 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