MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH ARTERIAL CLAMP - AC ARM LONG; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	ARTERIAL CLAMP - AC ARM LONG
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1 to a5: patient information was not provided.H11: livanova deutschland manufactures the arterial clamp.The incident occurred in spain.Serial read out files (real time device parameters and setting recording file) were collected, without proving the reported problem.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 that, during procedure, an essenz arterial clamp got stuck.Then, after being disconnected, it began to function correctly, but it stopped recognizing the centrifuge motor.There is no report of any patient injury.
Additional Manufacturer Narrative
H11.: no evidence was found to substantiate the customer¿s reported issue related to the affected arterial clamp.Reportedly, claimed event is most likely due to an improper setup of the essenz hlm and its associated components.Based on investigation findings, the event has been re-assessed as non-reportable, as no device malfunction occurred and the situation did not cause and the event is not likely to result in patient injury or death.
Event or Problem Description
See intial report.

• Brand Name: ARTERIAL CLAMP - AC ARM LONG
• 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: annarita di lascio ; arvada, CO 80004
• MDR Report Key: 23438516
• Report Number: 9611109-2025-90500
• Device Sequence Number: 4733470
• Product Code: DTQ
• UDI-Device Identifier: 04033817903116
• UDI-Public: (01)04033817903116(11)230921
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 01/19/2026

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: 09/01/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/21/2023
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown