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 Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.G.5.The heater-cooler 16-02-80 is not distributed in the usa and it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k220635).H11: livanova deutschland manufactures the 3t heater cooler system.The event occurred in the united states.A livanova field service engineer was dispatched onsite and confirmed the reported event.As troubleshooting, the patient pump 1 and the distribution board were replaced.Functional verification checks were completed successfully, and the unit was returned to service.A device complaints history review was performed and another similar event was reported since unit installation in 2016.No concerning trend was identified about this failure mode.Based on investigation findings, the root cause of the reported event has been attributed to a defective patient pump.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 report regarding a heater cooler 3t system showing the error (e16) concerning patient circuit 1.The issue occurred during procedure.There is no report of patient injury.

• 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): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: annarita di lascio ; 14401 w. 65th way; arvada 80004
• MDR Report Key: 24712940
• Report Number: 9611109-2026-90121
• Device Sequence Number: 6013168
• Product Code: DWC
• UDI-Device Identifier: 04033817900528
• UDI-Public: (01)04033817900528(11)161115
• 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): 03/27/2026

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
• 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: 02/25/2026
• Initial Report FDA Received Date: 03/30/2026
• Date Device Manufactured: 11/15/2016
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown