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	02/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: livanova deutschland manufactures the arterial clamp.The incident occurred in foggia, italy.Livanova initiated an investigation.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 an arterial clamp gave sometimes the following error message on cockpit screen of the essenz console: "arterial clamp: problem".In addition also configuration error messages related to arterial pump and cerebral one appeared.The issue occurred during priming.There was no patient involvement.
Event or Problem Description
See initial information.
Additional Manufacturer Narrative
H11: a picture confirming the error message has been provided by the customer an analyzing it, it can be stated that the error message popped up during the profile distribution phase.In addition, customer reported that no further issue have been occurred, 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: 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: 21526436
• Report Number: 9611109-2025-00092
• Device Sequence Number: 9584881
• Product Code: DTQ
• UDI-Device Identifier: 04033817903109
• UDI-Public: (01)04033817903109(11)240909
• 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 Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

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: 02/07/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2024
• 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