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

Model Number	CPD
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova deutschland manufactures the essenz cpd.Initial log analysis confirmed the alarm "art pump problem (e2353)" was displayed.The pump was replaced with alternative pump.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
During preparation for the essenz demo, an alarm occurred for "device (e2911) pump failure." the alarm history shows "art pump failure (e142)" and "art pump problem (e2353)." photos and error logs available.There was no patient involvement.
Additional Manufacturer Narrative
H11: the reported error code 2353 is associated with the secondary (redundant) system utilized by the hlm to monitor pump speed.This issue does not impact the functionality of the pump.According to the complaints database review, no further similar issues have been reported for this unit.Neither a concerning trend has been detected through the complaints data statistical analysis.Based on the above, the reported issue can be considered an isolated event.The root cause has been assigned to a temporary communication issue with the pump resolver on the hardware management system (hms) board.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.

• Brand Name: ESSENZ CPD
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80939 ; GM 80939
• 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: 22201342
• Report Number: 9611109-2025-90179
• Device Sequence Number: 20750100
• Product Code: DTQ
• UDI-Device Identifier: 04033817903031
• UDI-Public: (01)04033817903031(11)230703
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K232291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2025

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: CPD
• Device Catalogue Number: 60-04-50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 10/30/2025
• Date Device Manufactured: 07/03/2023
• 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