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	01/29/2026
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 the unit returned 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 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.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H11 a review of the device¿s service history confirmed that no similar events have been communicated to livanova since the date of manufacturing.A review of complaints database did not identify any trends associated with this failure mode.Based on investigation findings, the most likely root cause of the reported event was a temporary electrical failure, that was definitely solved during device technical service intervention.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: 24468836
• Report Number: 9611109-2026-90066
• Device Sequence Number: 13101572
• 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
• Report Date (Section B): 04/29/2026

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: 01/29/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 04/29/2026
• Date Device Manufactured: 06/29/2022
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown