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

Model Number	CONSOLE PLUS
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.- a.5.Patient information was not provided.H11: livanova deutschland manufactures the essenz roller pump 150.Livanova initiated an investigation.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 about an essenz hlm that showed the error message ¿art.Pump issue (2335)¿ related to the arterial pump, and the pump box was red with a wrench.The issue occurred after the case was completed with no patient impact.After the error message, the pump stopped and the perfusionist tried to increase the rpm of the pump, but it would not turn.Reportedly, the problem was solved by restarting the hlm; after that, the pump worked normally.

• Brand Name: ESSENZ
• 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: annarita di lascio ; arvada, CO 80004
• MDR Report Key: 24567235
• Report Number: 9611109-2026-90084
• Device Sequence Number: 8355229
• Product Code: DTQ
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2026

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
• Device Model Number: CONSOLE PLUS
• Device Catalogue Number: 10-90-00
• 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: 02/11/2026
• Supplement Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 07/14/2026
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown