MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND ARTERIAL CLAMP- AC ARM LONG (620 MM) - ESSENZ; 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	01/23/2025
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).Serial read out (real time device parameters and setting recording file) of the essenz hlm was collected.A clamp has currently been sent to the center, to replace the complained one and it has not yet been replaced.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, at the exit from the cec, the arterial clamp- ac arm long displayed alarm arterial clamp defective.The perfusionist tried to silence the alarm, removed the tube from the clamp and replaced it.After reopening the clamp from the cockpit, from there no more alarms.There is no report of any patient injury.
Additional Manufacturer Narrative
Cockpit log files were provided and the analysis confirmed the reported conditions: the error codes 1200 and 141 indicating a hardware problem were stored on the date of the event.The arterial clamp was returned for investigations: error could be reproduced and traced back to a faulty in the motor of the clamp the issue was traced back to a faulty motor, therefore the ac spindle and the ac stator have been replaced.The unit was manufactured in 2024, and the dhr review did not reveal any nonconformity related to the reported issue.The statistical analysis of the complaints database did not reveal any adverse trends concerning this failure mode.The root cause of the reported issue has been traced back to a defective ac motor.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: ARTERIAL CLAMP- AC ARM LONG (620 MM) - ESSENZ
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: antonella donatiello ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 21430802
• Report Number: 9611109-2025-00069
• Device Sequence Number: 4337186
• Product Code: DTQ
• UDI-Device Identifier: 04033817903116
• UDI-Public: (01)04033817903116(11)240917
• Combination Product (Y/N): N
• 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): 07/31/2025

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?: 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: 01/23/2025
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2024
• 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