MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH ESSEZ 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	05/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that, during a procedure, the venous clamp malfunctioned.The essenz cockpit displayed red box with a gear and an unlinked icon.Customer had to remove the tubing from the clamp and manually clamp.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 clamp.A livanova field service engineer was dispatched the customer and and troubleshooted venous clamp.The campl was calibrated and all necessary adjustments were made.However, the livanova fse couldn't get the fault the customer experienced.The clamp was tested repeatedly and the clamp was functioning as intended.Log files have been retrievedand sent it to manufacturer for investigation.The clamp has been returned to customer for use and is back in operation.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.
Additional Manufacturer Narrative
H11.A review of the device¿s 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 investigation findings, the event can be considered isolated, whose root cause cannot be fully determined.It cannot be ruled out that the most likely root cause was a temporary communication failure between the control unit and the clamp.The risk is in the acceptable region no specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: ESSEZ 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: antonella donatiello ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 22297992
• Report Number: 9611109-2025-90184
• Device Sequence Number: 12918746
• Product Code: DTQ
• Combination Product (Y/N): N
• PMA/510(K) Number: K232291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2026

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: 05/20/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown