MAUDE Adverse Event Report: LivaNova Deutschland Essenz Console Plus; 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	08/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that essenz venous clamp (vc) was not working properly, even if it was calibrated.As troubleshooting, the tube was removed and then placed in again but the problem was not solved.There was no patient injury.
Additional Manufacturer Narrative
A1-a5 patient information was not provided.H11 livanova field service engineer was disptached to customer facility to inspect the device.Log files were reviewed and no errors were found.Functional verification test was performend with no issue and the device returned to service in its expected functions.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: Essenz Console Plus
• 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: 50870563
• Report Number: 9611109-2026-90449
• Device Sequence Number: 10674053
• Product Code: DTQ
• UDI-Device Identifier: 04033817903062
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K232291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: 08/25/2026
• Initial Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 09/23/2025
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown