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	10/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova deutschland manufactures the essenz electronic venous clamp.Reportedly, the issue occurred only once, and the disposable in use was a livanova perfusion tubing system.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova deutschland received a report that, the electronic venous clamp went to 0% by itself even if it was set to 11% opening.The issue occurred at the end of the procedure.There is no report of any patient injury.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H11: a video was provided confirming the reported issue.A review of the device service history confirmed that no similar events have been communicated to livanova since the date of manufacturing.A review of complaints database did not identify any trends associated with this type of fault.Based on the investigation findings, it is reasonable to exclude an hardware malfunction of the venous clamp.However, the root cause of the reported issue remains undetermined.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 ; arvada, CO 80004
• MDR Report Key: 23479254
• Report Number: 9611109-2025-90507
• Device Sequence Number: 10237615
• Product Code: DTQ
• UDI-Device Identifier: 04033817903093
• UDI-Public: (01)04033817903093(11)240916
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2026

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 01/16/2026
• Date Device Manufactured: 09/16/2024
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown