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	05/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova deutschland manufactures the arterial clamp.The incident occurred in (b)(6).A replacement arterial clamp has been provided to the customer and the affected one will be shipped to livanova for 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 related to an issue of an arterial clamp used on an essenz console.In detail, at the time of de-clamping with poor venous return that led to repeated level alarms consequent closure of the arterial clamp occurred.Following one of these alarms the arterial clamp no longer opened, giving error messages related to "arterial clamp failed" (codes 141 and 1200).There was no patient injury.

• 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: 22201645
• Report Number: 9611109-2025-90180
• Device Sequence Number: 12673614
• Product Code: DTQ
• 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
• Report Date (Section B): 06/26/2026

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: 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: 05/16/2025
• Supplement Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2023
• 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