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

Model Number	120V/60 HZ
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	07/04/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Livanova received a report alleging that a heater-cooler system 3t device was used during a cardiac surgery performed on (b)(6) 2019 on the plaintiff patient, that resulted infected by mycobacterium chimaera on (b)(6) 2025.Patient is alive.
Additional Manufacturer Narrative
A.1.- a.5.Additional patient information was not provided.H.9.Livanova deutschland implemented a field safety notice for disinfection and cleaning of heater-cooler devices.The z number is z-2076/2081-2015.H11: a legal lawsuit has been initiated, and no additional information is currently available.No clinical or device-related information was provided.Furthermore, the specific surgical procedure remains unknown, and no medical records or laboratory results have been made available to confirm the reported event.Review of complaints database identified other similar contamination events from the same hospital, both on the same and other devices.Device history record review of the involved device serial number manufactured in april 2017 was conducted and did not identify any deviations or non-conformities relevant to the reported issue.The service history review revealed that vacuum and sealing kit upgrade was performed on 26 february 2020.Based on the available information, source of patient contamination and involvement of the device remains unknown.Livanova has implemented a strategy to progressively decrease the probability of bacteria grow in the hc device by applying multiple measures implemented over the past few years through dedicated capa.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: 3T Heater/Cooler
• Common Device Name: Controller, Temperature, Cardiopulmonary Bypass
• Manufacturer (Section D): LivaNova Deutschland; lindberghstrasse 25; munich 80939 ; GM 80939
• MDR Report Key: 50802319
• Report Number: 9611109-2026-90433
• Device Sequence Number: 10610988
• Product Code: DWC
• UDI-Device Identifier: 04033817900528
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/17/2026
• Report Date (Section F): 09/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 120V/60 HZ
• Device Catalogue Number: 16-02-85
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/18/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2017
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2076/2081-2015
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male