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

Model Number	CPD
Medical Device Problem Code	Failure to Auto Stop (2938)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: livanova deutschland manufactures the essenz cpd.A livanova field service engineer was dispatched the customer and log and low levelbubble sensor log were obtained.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 end of the procedure, after having recovered patient blood still inside the artery line, the essenz centrifugal pump blocked at 1400 rpm sped and dit not allow the operator to bring it to 0 rpm.Operator overcome the problem after several attempts.There is no report of any patient injury.

• 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): MUNICH; lindberghstrasse 25; munich AL 80939 ; GM 80939
• Manufacturer Contact: antonella donatiello ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 22187026
• Report Number: 9611109-2025-90176
• Device Sequence Number: 8588973
• Product Code: DTQ
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2026

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: 05/12/2025
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/14/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown