MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND 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	10/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: through follow up communications, it was learned that the customer solved the issue by unplugging and replugging the cable to the control unit (cu) that controlled the arterial pump.Livanova field service engineer was dispatched to the customer facility.The serial read out files (real time device parameters and setting recording file) were collected and analysed and the claimed error code was error 2335.According to the information recorded, the message was cleared after one minute, and after a couple of minutes, the cable going to the cu might have been pulled off, which generated error code 2356.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 that the essenz heart lung machine arterial pump stopped while at low flow values.The issue occurred during procedure.There is no report of any patient injury.
Additional Manufacturer Narrative
H11: a review of device service history confirmed that the reported event represents the first occurrence associated with this device.No adverse trend related to this failure mode was identified.Based on the available information, the reported event is considered non-systematic, and the root cause of the occurrence could not be conclusively established.Nevertheless, considering that the pump resumed normal operation following a console reboot, it cannot be excluded that a transient and non-persistent hardware malfunction of an internal component may be considered a potential contributing factor associated with the reported behavior.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
• 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: 23669567
• Report Number: 9611109-2025-90562
• Device Sequence Number: 18637909
• 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 Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 11/28/2025
• Supplement Report FDA Received Date: 04/13/2026
• Date Device Manufactured: 07/02/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown