MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND ESSENZ; 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	12/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H11: 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 of an error message related to an essenz venous clamp displayed onto the unit ("vc defective").Subsequently, the clamp was calibrated and could work properly.The event occurred out of procedure.There was no patient involvement.
Additional Manufacturer Narrative
H11: through follow-up communication it was learned that, when the alarm occurred, the user unplugged and replugged the venous clamp.This temporarily restored normal operation before the alarm was triggered again.Device shall be repaired.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
See initial report.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
D.4.Through follow up communication serial number of the complained device has been provided.Udi and manufacturing date have been updated accordingly.H11.Investigation is ongoing.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
The complained venous clamp was returned at manufacturing site: device problem was not reproduced.After performing calibration and functional tests with positive results, the unit was put back into regular service.A review of the device¿s service history confirmed that no similar events occurred since device date of manufacturing.A review of complaints database did not identify any trends associated with this type of fault.Based on the investigation findings and considering that no device problem was identified, a hardware mechanical malfunction can be ruled out.The most likely root cause of the reported event is an intermittent communication failure or transient mechanical resistance during the movability test.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
See initial report.

• Brand Name: ESSENZ
• 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: 23904696
• Report Number: 9611109-2025-90635
• Device Sequence Number: 21149811
• Product Code: DTQ
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K232291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/01/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2025
• Supplement Date Received by Manufacturer: 12/23/2025; 01/26/2026; 03/03/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 01/21/2026; 02/25/2026; 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/16/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown