MAUDE Adverse Event Report: LivaNova Deutschland Venous Clamp; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	NG-EVO - KLEMMEINHEIT
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 the essenz venous clamp (vc) displayed an error code indicating that the clamp was defective (e2551).The issue occurred during the procedure.There was no patient injury.
Additional Manufacturer Narrative
A1-a5 patient information was not provided.H11 reportedly, the device was calibrated approximately one hour before use.During weaning from cardiopulmonary bypass, the user observed that when the clamp was set to 50% closure, venous flow remained at approximately 4.2 l/min, indicating limited occlusion.When adjusted to 18%, the clamp fully occluded the venous line.Subsequent attempts to reopen the clamp to 25% were unsuccessful, as the setting repeatedly returned to 0%.As a result, the user removed the clamp from the holder and managed venous drainage manually.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: 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 80004
• MDR Report Key: 50897289
• Report Number: 9611109-2026-90455
• Device Sequence Number: 20296697
• Product Code: DTQ
• UDI-Device Identifier: 04033817903093
• UDI-Public: (01)04033817903093(11)260408
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 09/25/2026

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: NG-EVO - KLEMMEINHEIT
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/25/2026
• Date Device Manufactured: 04/08/2026
• Patient Sequence Number: 1
• Patient Sex: Unknown