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

Model Number	VENOUS CLAMP
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that an essenz heart-lung machine (hlm) venous clamp (vc) displayed the error message "vc defective" (error code 2551).The issue occurred during procedure.There is no report of any patient injury.
Additional Manufacturer Narrative
A1-a5: patient information was not provided.H11: livanova deutschland manufactures the essenz venous clamp (vc).The event occurred in (b)(6), usa.Livanova has initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: ESSENZ VENOUS CLAMP
• 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
• MDR Report Key: 24688631
• Report Number: 9611109-2026-90109
• Device Sequence Number: 10041950
• Product Code: DTQ
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 03/25/2026

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: VENOUS CLAMP
• Device Catalogue Number: 12-80-40
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 03/25/2026
• Date Device Manufactured: 08/25/2023
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown