MAUDE Adverse Event Report: LIVANOVA DEUTCHLAND 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	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova deutschland manufactures the 3t heater cooler system.The event occurred in jackson, united states.A livanova field service representative was dispatched to the facility to investigate the device and was unable to calibrate or get into device service mode, so the processor board was replaced.The device was then calibrated and, after performing all the functional tests with positive results, it was sent back to service.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 regarding a heater cooler 3t system, showing the error e04 reporting that the temperature difference of the temperature sensors in the control/safety system is too big.The issue occurred during procedure.There is no report of patient injury.

• Brand Name: HEATER-COOLER 3T SYSTEM
• Common Device Name: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTCHLAND; 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 80004
• MDR Report Key: 24528650
• Report Number: 9611109-2026-90075
• Device Sequence Number: 18578494
• Product Code: DWC
• UDI-Device Identifier: 04033817900528
• UDI-Public: (01)04033817900528(11)161205
• 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): 03/06/2026

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: 02/04/2026
• Initial Report FDA Received Date: 03/06/2026
• Date Device Manufactured: 12/05/2016
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown