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

Model Number	NG-EVO - KLEMMEINHEIT
Medical Device Problem Code	Unstable (1667)
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 about multiple error messages "venous clamp defective" related to the an essenz electronic venous clamp (evo), displayed on the relative essenz hlm console.There is no report of any patient injury.
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova deutschland manufactures the essenz electronic venous clamp.The incident occurred in the united states.A livanova field service technician dispatched on-site confirmed the device malfunction and the error message ¿vc defective.¿ to solve the issue, the venous clamp was replaced with a new unit.The functional verification tests were performed successfully and the unit was released to the customer in full working order.Cockpit event logs were provided for analysis and confirmed the error 2551 associated with the header ¿vc defective¿.This error code 2551 indicates that the motor of the venous clamp (vc) is defective.A device service history review was performed and identified that the affected clamp was manufactured in 2024, and no other similar events have been reported, nor has a concerning trend been detected.Based on the investigation findings, it is reasonable to trace the root cause of the issue to a faulty electro-mechanical component of the venous clamp motor.The wearing of electro-mechanical device can be originated by the specific use conditions at customer site that may have contributed to the event.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: ELECTRONIC VENOUS CLAMP
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 24664975
• Report Number: 9611109-2026-90108
• Device Sequence Number: 9289634
• Product Code: DTQ
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/23/2026

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
• Device Model Number: NG-EVO - KLEMMEINHEIT
• Device Catalogue Number: 12-80-40
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 03/23/2026
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown