MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND ESSENZ ARTERIAL CLAMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	ARTERIAL CLAMP - AC ARM LONG
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that an essenz arterial clamp (ac) gave the following error message (2450 code) "ac defective" during procedure.Even changing the port on the power pack and pressing the circuit breaker button on the ac, the issue and the error message persist.There was no patient injury.
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova deutschland manufactures the essenz arterial clamp.The incident occurred in torino, italy.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
H11: the affected part was returned to livanova for a detailed investigation.Immediately upon powering on the machine, the error message "clamp defective" appeared on the screen associated with the error codes 1200 and 2393.Error messages were reproducible and systematic.The clamp was then opened and visually inspected.Massive traces of liquids were found inside affecting boards and wirings causing the reported condition.The root cause of the event is traced back to liquid penetration ( e.G.Saline solution) inside the internal components, leading to the reported malfunction.The clamp is not reparable and will be scrapped.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
H11: affected clamp was replaced by a new one.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: ESSENZ ARTERIAL 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: 22455912
• Report Number: 9611109-2025-90235
• Device Sequence Number: 8395083
• Product Code: DTQ
• UDI-Device Identifier: 04033817903116
• UDI-Public: (01)04033817903116(11)240119
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K221373
• 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
• Report Date (Section B): 11/05/2025

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: ARTERIAL CLAMP - AC ARM LONG
• Device Catalogue Number: 60-05-35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Supplement Date Received by Manufacturer: 07/09/2025; 10/31/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 08/08/2025; 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2024
• 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