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	10/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1-a5 patient information was not provided.H11 livanova deutschland manufactures the essenz arterial clamp, the event occurred in united states.Livanova field service engineer confirmed the issue, and to fix it, the arterial clamp has been replaced.
Event or Problem Description
Livanova deutschland received a report that the essenz arterial clamp was not working properly.Reportedly, the plastic fixture that engages when opening or closing the clamp was not moving.There is no patient involvement.
Additional Manufacturer Narrative
A review of device service history confirmed that the reported event represented the first occurrence associated with the specific unit.No adverse trend associated to this failure mode occurred.Based on the investigation findings of similar incidents, a hardware failure affecting the white plastic fixture of the clamp is identified as a possible contributing factor and cannot be excluded as a primary element related 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 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: 23826751
• Report Number: 9611109-2025-90602
• Device Sequence Number: 5080239
• Product Code: DTQ
• UDI-Device Identifier: 04033817903062
• UDI-Public: (01)04033817903062(11)241121
• 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
• Operator of Device: Health Professional
• Device Model Number: CONSOLE PLUS
• 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: 11/17/2025
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 03/24/2026
• Date Device Manufactured: 11/21/2024
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown