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	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1-a5 patient information was not provided.H11 livanova deutschland manufactures the heater cooler 3t system, the issue occurred in the united states.Livanova field service engineer was dispatched to customer facility, checked the device and could not replicate the issue.Technical safety inspection was perfomed successfully and device was sent back to customer 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
Livanova deutschland received report that the heater cooler 3t system heating function was not working properly.Reportedly, device stopped at 27°c even if set temperature was 37°c.There was no patient impact.
Additional Manufacturer Narrative
Based on follow up communications, it was clarified that this event is a recurrence of the same problem, that was not replicated by field service engineer dispatched onsite.When a second service activity was performed, the event was confirmed and the distribution board, mains transformer and mains ac kit have been replaced.After performing all the functional tests with positive results, unit was sent back to customer 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.

• 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: 24598124
• Report Number: 9611109-2026-90090
• Device Sequence Number: 9561041
• Product Code: DWC
• UDI-Device Identifier: 04033817900528
• UDI-Public: (01)04033817900528(11)220629
• 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,Followup,Followup
• Report Date (Section B): 05/19/2026

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
• 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: 02/13/2026
• Supplement Date Received by Manufacturer: 03/19/2026; 04/24/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 04/17/2026; 05/19/2026
• Date Device Manufactured: 06/29/2022
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown