MAUDE Adverse Event Report: LivaNova Deutschland 3T Heater/Cooler; Controller, Temperature, Cardiopulmonary Bypass

Model Number	120V/60 HZ
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report of a 3t heater/cooler which suddenly shut off during usage.The event occurred during a procedure.There was no patient injury.
Additional Manufacturer Narrative
H11: a livanova field service engineer (fse) was dispatched on site and the event was not confirmed.A full functional verification and electrical safety inspection was performed onto involved unit, and all measured parameters were found to be within manufacturer-specified operating tolerances and standard specifications.Consequently, unit was returned back to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: 3T Heater/Cooler
• 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: 50836112
• Report Number: 9611109-2026-90437
• Device Sequence Number: 13276923
• Product Code: DWC
• UDI-Device Identifier: 04033817900528
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: 120V/60 HZ
• Device Catalogue Number: 16-02-85
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown