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

Model Number	60-05-30
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that an arterial clamp gave the error message "arterial clamp defective" at setup.The was no patient injury.
Additional Manufacturer Narrative
There was no patient involvement.H11: livanova deutschland manufactures the arterial clamp.The incident occurred in albuquerque, new mexico.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.In order to solve the issue, the affected clamp was replaced with a new one.Subsequent functional verification testing was completed without further issues and the unit was returned to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
Complaints database analysis revealed no similar event since unit installation in 2024 and no adverse and no concerning trends about the reported failure mode have been identified.Dhr review has been performed and no non-conformity relevant to the issue was found.Based on all the collected elements, it is likely to assume that the cause of the problem is a faulty component inside the claimed ac.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: ARTERIAL CLAMP
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: antonella donatiello ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 21523858
• Report Number: 9611109-2025-00089
• Device Sequence Number: 12846983
• Product Code: DTQ
• UDI-Device Identifier: 04033817903109
• UDI-Public: (01)04033817903109(11)240711
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K232291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 05/19/2025

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: 60-05-30
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2024
• 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