MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND HEATER-COOLER 3T SYSTEM; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number	HEATER/COOLER 3T 208V/60HZ
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A livanova field service engineer was dispatched the customer and the 3t hc power off was not reproducible, patient tank did not suck water back into the system when venting valve was closed and patient tank alarming empty when it was full was reproducible.The float assembly was stuck as a result the float assembly was replaced.The distribution board was replaces to solve the issue of not sucking water back.The circulatory motor was replaced since it was no working.The 3t was functionally tested, preventive maintenance completed and the device was returned to customer.A possible explanation is that the customer noticed that the patient tank was not working as intended and reported a power off of the device.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.
Event or Problem Description
See intial report.
Additional Manufacturer Narrative
H11: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova deutschland received a report that a heater-cooler system 3t device powered off during procedure.There was no patient injury.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H11 a review of the device¿s service history confirmed that no similar events have been communicated to livanova since device date of manufacturing.A review of complaints database did not identify any trends associated with this failure mode.The most likely root cause of the reported event is water infiltration as well as prolonged exposure to elevated temperatures and high humidity levels during the stationary phase.These factors are related to environmental conditions and may have been further intensified by the disinfection procedure.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: HEATER-COOLER 3T SYSTEM
• 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 80309 ; GM 80309
• Manufacturer Contact: antonella donatiello ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 22646245
• Report Number: 9611109-2025-90271
• Device Sequence Number: 15652989
• Product Code: DWC
• UDI-Device Identifier: 04033817900511
• UDI-Public: (01)04033817900511(11)171025
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2026

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 208V/60HZ
• Device Catalogue Number: 16-02-82
• 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: 06/30/2025
• Supplement Date Received by Manufacturer: 08/12/2025; 03/13/2026
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 09/11/2025; 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown