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	11/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H11: essenz cockpit log files were retrieved and analysed, confirming the reported event.Two error codes were highlighted (4421, 4441), which indicated a timeout of the backup control unit which was connected to the arterial pump.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, during preliminary testing of the level alarm, the arterial pump did not drop to 1400 rounds per minutes (rpm) but suddenly stopped.Perfusion rebooted the hlm, repeated the test and passed positively.The event occurred during initial setup.There was no patient involvement.
Additional Manufacturer Narrative
H11: through follow-up communication, it was learnt that, after performing all the functional tests with positive results, the whole essenz hlm was returned to service in its expected functions.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H11: the reported event concerns the "art.Pump rebooted" alarm message, indicating that the control unit connected to the arterial pump experienced a timeout, leading to a self-restart of the pump to resume normal operation.In such scenarios, as per device software requirement specifications, the control unit shall detect a possible watchdog reset and automatically restore any previously assigned role and intervention linkage within 5 seconds after completion of the reset.After the control unit reset, the pump shall stop, and the user needs to turn the control knob to operate the pump, as suggested in the device instruction for use (ifu).Based on the above, the reported event has been re-assessed as not reportable, since it unlikely to result in death or serious injury, even if it recurs.
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: 23767801
• Report Number: 9611109-2025-90586
• Device Sequence Number: 10615841
• Product Code: DTQ
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 03/31/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 01/09/2026; 03/06/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 02/06/2026; 03/31/2026
• Date Device Manufactured: 09/13/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown