MAUDE Adverse Event Report: LivaNova Deutschland 3T Heater/Cooler; 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	08/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report of a 3t heater/cooler for which an error message was displayed (e07, "pump 1 is blocked (too slow)").The event occurred during procedure.There was no patient injury.
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: a livanova field service engineer (fse) was dispatched on site: the event was confirmed, into which the patient side pump was involved.The stirrer motor was seized and unable to rotate.As troubleshooting, the service technician successfully released it manually, then a replacement patient bridge was ordered.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: 50773484
• Report Number: 9611109-2026-90428
• Device Sequence Number: 21188398
• 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): 09/15/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown