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	02/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: livanova deutschland manufactures the essenz electronic venous clamp.The event occurred in (b)(6) norway.Livanova initiated an investigation.Through follow-up communication it was learned that the issue occurred during the reperfusion phase and appeared in a sporadic manner.Furthermore, it was reported that a pvc tube was used.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 about an electronic essenz venous clamp (evo), whose control unit showed 39% opening value while it was closed, despite having been calibrated.On another occasion, the clamp indicated 1% opening value while it was fully open.There is no report of any patient injury.

• 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: 24544923
• Report Number: 9611109-2026-90079
• Device Sequence Number: 21178646
• Product Code: DTQ
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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,Followup
• Report Date (Section B): 05/08/2026

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
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 05/08/2026
• Date Device Manufactured: 04/28/2025
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown