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

Model Number	CONSOLE PLUS
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1-a5 patient information was not provided.H11.Livanova deustchland manufactures the essenz hlm, the event occurred in united states.Livanova 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
Livanova deutschland received a report that the essenz hlm showed the error message arterial clamp defective.The issue occurred during procedure.There is no report of any patient injury.
Additional Manufacturer Narrative
H11: no service intervention was performed and no additional information or diagnostic data could be obtained.A review of device service history confirmed that the reported event represented the first occurrence associated with the specific unit.No adverse trends related to this failure mode occurred.Based on the information available to date, the root cause of the event could not be conclusively determined.Nevertheless, a non-persistent hardware malfunction affecting the clamp cannot be ruled out and is identified as a potential contributing factor to the reported behavior.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
See initial 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 ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 23770506
• Report Number: 9611109-2025-90590
• Device Sequence Number: 9751608
• Product Code: DTQ
• UDI-Device Identifier: 04033817903062
• UDI-Public: (01)04033817903062(11)240510
• 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,Followup
• Report Date (Section B): 03/24/2026

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: 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: 02/25/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 03/24/2026
• Date Device Manufactured: 05/10/2024
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown