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	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
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, the incident occurred in united kingdom.A livanova field service engineer was dispatched at the customer site and confirmed the circulation motor to be faulty.To solve the problem, circulator motor was replaced, along with the distribution and processor board.Subsequently, all the functional tests passed with positive results and unit was sent back to customer in its expected functions.A complaints database review was performed and revealed that no similar event was received for this unit since installation in 2025.Based on the investigation findings, the root cause of the reported event has been attributed to an early failure of the circulation motor and electrical boards.Failure of electronic boards can be related to multiple and not deterministic factors such as exposure to heat, dust and moisture, accidental impact (drops and falls), and power overloads/surges but also to variability of micro subcomponents.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
Livanova deutschland received a report that the heater cooler 3t system displayed alarm pump 1 uses too much power (e06) and is blocked on machine patient side.Burning smell was also reported.The issue occurred during procedure.There is no patient involvement.

• 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): LIVANOA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: annarita di lascio ; 14401 w. 65th way; arvada 80004
• MDR Report Key: 24699951
• Report Number: 9611109-2026-90113
• Device Sequence Number: 10467489
• Product Code: DWC
• UDI-Device Identifier: 04033817900528
• UDI-Public: (01)04033817900528(11)250714
• 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
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/26/2026

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: 02/24/2026
• Initial Report FDA Received Date: 03/26/2026
• Date Device Manufactured: 07/14/2025
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown