MAUDE Adverse Event Report: MUNICH 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	03/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that the heater cooler 3t system was not cooling properly and seemed to be stuck.The event occurred during priming.There was no patient impact.
Additional Manufacturer Narrative
H11.Livanova deutschland manufactures the heater cooler 3t system.The event occurred in the united states.Livanova field service engineer was dispatched on site, inspected the device and confirmed that the unit does not start cooling unless either the patient circuit or the cardioplegia circuit is actively circulating.Also, the cooling time resulted higher than device manufacturing specifications.As part of the troubleshooting activities, the ribbon cable connecting the cpu to the distribution board and the power supply were replaced, without solving the problem.According to manufacturer technical service support, the refrigerant shall be recharged.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: HEATER COOLER 3T SYSTEM
• Common Device Name: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MUNICH; 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: 24883098
• Report Number: 9611109-2026-90148
• Device Sequence Number: 10330900
• Product Code: DWC
• UDI-Device Identifier: 04033817900528
• UDI-Public: (01)04033817900528(11)200909
• 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
• Report Date (Section B): 07/14/2026

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 04/15/2026
• Supplement Report FDA Received Date: 07/14/2026
• Date Device Manufactured: 09/09/2020
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown