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

Model Number	CONSOLE PLUS
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland has received a report concerning an essenz heart-lung machine (hlm) cockpit that briefly blacked out after the perfusionist reversed the pump direction during a procedure.No patient injury has been reported.
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova deutschland manufactures the essenz hlm system referenced in this report.The event occurred in zurich, switzerland.Livanova has been informed that the issue occurred after the perfusionist reversed the direction of the cardioplegia pump during the final stage of the procedure, in the early afternoon.It was further reported that the cockpit briefly blacked out for approximately two seconds before resuming normal functionality.The livanova logo did not appear upon recovery, and the perfusionist found the system already in bypass mode when the cockpit resumed operation.The investigation is currently ongoing.

• Brand Name: ESSENZ CONSOLE PLUS
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 24556530
• Report Number: 9611109-2026-90082
• Device Sequence Number: 9422022
• Product Code: DTQ
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K232291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/10/2026

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: CONSOLE PLUS
• Device Catalogue Number: 49-00-10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 03/10/2026
• Date Device Manufactured: 07/02/2024
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown