MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH ARTERIAL CLAMP- AC ARM LONG (620 MM); CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	60-05-35
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information were not provided.H11: livanova deutschland manufactures the arterial clamp- ac arm long (620 mm).A livanova field service representative was dispatched to the facility to investigate the device and could not reproduce the issue.During observation, a loose screw was located inside of the arterial clamp.Perform visual inspection, electrical safety inspection, functional safety inspection and tested modules.Tested all okay, unit is back in service.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 procedure, the arterial clamp was defective.There is no report of any patient injury.

• Brand Name: ARTERIAL CLAMP- AC ARM LONG (620 MM)
• 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: 21992668
• Report Number: 9611109-2025-90109
• Device Sequence Number: 14518872
• Product Code: DTQ
• Combination Product (Y/N): N
• PMA/510(K) Number: K221373
• 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): 05/22/2026

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: 60-05-35
• Device Catalogue Number: 60-05-35
• 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: 04/10/2025
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown