MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND ESSENZ - ARTERIAL CLAMP - AC ARM SHORT; 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	02/07/2025
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 priming, the alarm arterial clamp problem was displayed.Customer provided photografic evidences.There was no patient involvement.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H11: from the picture provided by the customer and analyzed, it can be stated that the error message popped up during the profile distribution phase.Furthermore, through follow-up communication with the customer livanova learned that no further issue have been occurred on this unit, thus excluding a hardware defect.Complaints database analysis revealed no adverse and concerning trends about the reported failure mode have been triggered by periodical complaints statistical analysis.Based on the collected information, a hardware defect of the clamp can be ruled out.However, considering that the issue occurred during the profile loading , it cannot be ruled out that a temporary isolated communication issue between the ac (alternating current) and the can (controller area network) bus occurred.

• Brand Name: ESSENZ - ARTERIAL CLAMP - AC ARM SHORT
• 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: 21526467
• Report Number: 9611109-2025-00093
• Device Sequence Number: 15881030
• Product Code: DTQ
• UDI-Device Identifier: 04033817903109
• UDI-Public: (01)04033817903109(11)240820
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2025

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/20/2024
• 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