MAUDE Adverse Event Report: LIVANOVA DEUTCHLAND ESSENZ ARTERIAL CLAMP - AC ARM SHORT; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	ARTERIAL CLAMP - AC ARM SHORT
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report about alarm "arterial clamp defective" appeared on an essenz cockpit, related to the essenz arterial 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 arterial clamp - ac arm short (500mm).A field service engineer dispatched onsite confirmed the event; even if changing connection ports, clamp continued to give the same error.The device was therefore opened and dirt and loose screw were found inside.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: ESSENZ ARTERIAL CLAMP - AC ARM SHORT
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTCHLAND; 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: 24442623
• Report Number: 9611109-2026-90061
• Device Sequence Number: 10307759
• Product Code: DTQ
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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
• 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 SHORT
• Device Catalogue Number: 60-05-30
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 06/26/2026
• Date Device Manufactured: 07/31/2024
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown