MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH HEATER-COOLER SYSTEM 3T; 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	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H.11: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in the united states of america.Livanova's field service engineer was dispatched on customer's facility and confirmed all the reported issues on the unit.As a troubleshooting for addressing error 03 (e03), the mains ac board of the unit was replaced.Inspection identified a failed circulator motor causing the e07 error and burning smell, thus the motor was replaced.Also, diagnostic revealed the e51 heating-element error was caused by faulty patient and cardioplegia circuit bridges, leading to their replacement.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
Livanova received a report of a heater-cooler 3t system displaying multiple errors on patient side (e03, e07, e55, e58).The issue occurred during procedure.There is no report of patient/user injury.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Common Device Name: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 24389941
• Report Number: 9611109-2026-90054
• Device Sequence Number: 10518458
• Product Code: DWC
• UDI-Device Identifier: 04033817900528
• UDI-Public: (01)04033817900528(11)170502
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2026

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
• Device Catalogue Number: 16-02-85
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 02/19/2026
• Date Device Manufactured: 05/02/2017
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown