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

Model Number	ARTERIAL CLAMP- AC ARM LONG (620 MM)
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2024
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).Cockpit logs provided and checked.The claimed message (e1200) was recorded in a couple of cases when entering a case.The message did not re-present itself within the same case.As indicated by the fse, after a couple of times the machine was rebooted, the error disappeared.No deviations in the function of the ac were noted.The clamp was asked back for further analysis.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 arterial clamp displayed "arterial clamp defective" message during a procedure.Message shown and the arterial clamp remained completely functional.Message disappeared after rebooting a couple of times the unit.There is no report of any patient injury.
Additional Manufacturer Narrative
The ac was requested for further testing, received and inspected.No significant external defect could be observed.The clamp was connected to a test essenz hlm and simulation tests were executed.The clamp always behaved as intended and no error messages were displayed.The clamp was opened to evaluate the internal condition of the item and visible defect were noticed.Eventually, the clamp was connected to an automated test bench and tested for 24 hours (opening and closing commands given to the clamp for 24 hours).No deviations could be detected.A review of the service history of the device has been conducted, indicating that the ac was manufactured in 2023 and no other similar events have been reported.No trends regarding the reported type of issue have been detected.Based on the collected information, the issue was confirmed via log analysis but the root cause of the event remains undetermined as the problem could not be reproduced.It cannot be ruled out that the issue was caused by a temporary electrical communication issue between the ac and the system, which resulted in the claimed error message.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 intial report.

• Brand Name: ESSENZ
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: antonella donatiello ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 20532388
• Report Number: 9611109-2024-00501
• Device Sequence Number: 6697597
• Product Code: DTQ
• UDI-Device Identifier: 04033817903116
• UDI-Public: (01)04033817903116(11)231219
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K221373
• 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): 09/05/2025

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 LONG (620 MM)
• Device Catalogue Number: 60-05-35
• 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: 09/27/2024
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2023
• 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