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

Model Number	COCKPIT COMPLETT
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received report of an essenz hlm cockpit whose knobs stopped operating during priming.System was rebooted, but the issue persisted.After 4 minutes, the cockpit screen showed up.During that time only the arterial knob worked.The back-up control panel was never used as trial.Case was then completed successfully.The event occurred during procedure.There was no patient injury.
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova has started an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: ESSENZ HLM
• 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 ; arvada, CO 80004
• MDR Report Key: 23632908
• Report Number: 9611109-2025-90550
• Device Sequence Number: 10314880
• Product Code: DTQ
• UDI-Device Identifier: 04033817903048
• UDI-Public: (01)04033817903048(11)250204
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Report Date (Section B): 11/24/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 11/24/2025
• Date Device Manufactured: 02/04/2025
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown