MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH ARTERIAL CLAMP - AC ARM SHORT (500MM) - ESSENZ; 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	04/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no known patient involvement.H11: livanova deutschland manufactures the arterial clamp - ac arm short (500mm).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 a demonstration of the centrifugal pump, the arterial clamp did not close on a level alarm.Even after a complete restart, it didn¿t react.The level was removed from the profile and inserted it again, after that, the arterial clamp reacted as it should.There was no patient involvement.
Additional Manufacturer Narrative
H11 following a review of the complaints database, no similar issues have been reported since the device manufacturing date, and no concerning trend has been identified.Based on the information provided, a hardware malfunction of the clamp or level sensor can be ruled out.The root cause of the issue is therefore attributed to a temporary communication failure.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
See initial report.

• Brand Name: ARTERIAL CLAMP - AC ARM SHORT (500MM) - ESSENZ
• 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 ; arvada, CO 80004
• MDR Report Key: 21917085
• Report Number: 9611109-2025-90087
• Device Sequence Number: 8715376
• Product Code: DTQ
• UDI-Device Identifier: 04033817903109
• UDI-Public: (01)04033817903109(11)240529
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 12/01/2025

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 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: 04/02/2025
• Supplement Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2024
• 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