MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND HEATER COOLER 3T SYSTEM; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number	HEATER/COOLER 3T 120V/60 HZ
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that the heater cooler 3t system patient side heating function was not working properly.The event occurred during procedure.There was no patient impact.
Additional Manufacturer Narrative
A1-a5 patient information was not provided.H11 livanova deutschland manufactures the heater cooler 3t system, the event occurred in united states.Livanova field service engineer was dispatched to customer facility to inspect the device.The issue was confirmed and in order to fix it the a/c board and patient circuit bridge were replaced.Following the intervention, a functional verification test was run and successfully completed, and the unit was returned to service.A review of the device¿s service history confirmed that no similar events have been communicated to livanova since device date of manufacturing.Based on the investigation findings, the root cause of the event was attributed to an electric/electronic problem of the replaced components, most likely resulting from cumulative wear over time.The wearing of electro-mechanical devices can be originated by the specific use condition at customer site that may have contributed to the event, such as movements or liquids penetration.However, there is no concerning trend for this kind of failure.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: HEATER COOLER 3T SYSTEM
• Common Device Name: CONTROLLER, TEMPERATURE, 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: 24874445
• Report Number: 9611109-2026-90147
• Device Sequence Number: 9100621
• Product Code: DWC
• UDI-Device Identifier: 04033817900528
• UDI-Public: (01)04033817900528(11)160404
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K220635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/14/2026

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
• Operator of Device: Health Professional
• Device Model Number: HEATER/COOLER 3T 120V/60 HZ
• Device Catalogue Number: 16-02-85
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 04/14/2026
• Date Device Manufactured: 04/04/2016
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown