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

Model Number	208V/60HZ
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report of a 3t heater/cooler for which the patient pump was found to not work properly.The issue was highlighted during a service intervention.There was no patient involvement.
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H11: livanova field service engineer replaced involved patient pump.Device was tested and found to be aligned with all specifications.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: 50835487
• Report Number: 9611109-2026-90436
• Device Sequence Number: 16019962
• Product Code: DWC
• UDI-Device Identifier: 04033817900511
• 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: 208V/60HZ
• Device Catalogue Number: 16-02-82
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown