MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH ESSENZ ARTERIAL CLAMP; 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	07/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova deutschland manufactures the arterial clamp.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 of a noisy and defective essenz arterial clamp during a procedure.There is no report of any patient injury.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
D4: model and serial number of the involved essenz arterial clamp has been provided and dedicated sections have been updated accordingly.H4: device manufacturer date has been updated.H11: a livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue: noisy defective arterial clamp was reproducible.Therefore, in order to solve it, a new arterial clamp was installed.Subsequent functional verification testing was completed without issues and the unit was put back on service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
The complained clamp was returned to manufacturer for testing and the issue reproduced after around 3 hours of testing: error messages "arterial clamp defective" was displayed, with error codes 141 and 1200.Errors indicate that the erc has not fulfilled the command and it will not work.Unusual noise was noticed, likely coming from the the arterial clamp motor that could not operate properly.Clamp was then dismounted, and sticky residues were noticed on the spindle block, washers and housing.This could have caused the reported issue.Clamp will be cleaned and repaired before returning to customer.A device service history review has been performed and identified that the unit was manufactured in 2023 and no other similar event has been reported for current clamp, but other two events of noisy clamps were reported from same customer.Based on the gathered information, the most likely root cause of the reported event has been assigned blocked spindle, due to fluid residues accumulated over time due to improper cleaning of the device.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 initial report.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
During repair activity by tssi technician the can connector on the zkb board was found in the wrong position and therefore the board replaced and properly reconnected.Can connector was most likely reconnected wrongly during investigation of internal parts and replacement of board may be related to this improper connection.Since issue was reproduced during investigation prior to internal inspection of device and strange noise was confirmed during testing, root cause remains related to dried/sticky residues found inside the device.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: ESSENZ ARTERIAL CLAMP
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: antonella donatiello ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 20049833
• Report Number: 9611109-2024-00383
• Device Sequence Number: 20844101
• Product Code: DTQ
• UDI-Device Identifier: 04033817903116
• UDI-Public: (01)04033817903116(11)230914
• Combination Product (Y/N): N
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/18/2025

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: 60-05-35
• Was Device Available for Evaluation?: No
• 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: 07/25/2024
• Supplement Date Received by Manufacturer: 08/05/2024; 04/09/2025; 06/18/2025
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 09/03/2024; 05/08/2025; 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2023
• 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