FDA Adverse Event Injury Summary report: N

HEATER-COOLER 3T SYSTEM

MDR report key: 23876407 · Received December 23, 2025

Report

Report Number: 9611109-2025-90622
Event Type: Injury
Date Received: December 23, 2025
Date of Event: March 16, 2016
Report Date: December 23, 2025
Manufacturer: LIVANOVA DEUTSCHLAND
Product Code: DWC
Removal / Correction Number: Z-2076/2081-2015
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

A1-A5 PATIENT INFORMATION WAS NOT AVAILABLE. D.4. SERIAL NUMBER IS UNKNOWN. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. G.5. THE HEATER-COOLER 16-02-82 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). 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 LIVANOVA DEUSTCHLAND MANUFACTURES THE HEATER COOLER 3T SYSTEM, THE ISSUE OCCURRED IN CANADA. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem · 0

LIVANOVA RECEIVED A REPORT IN WHICH IT IS ALLEGED THAT A HEATER-COOLER 3T SYSTEM CAUSED PATIENT MYCOBACTERIUM CHIMAERA INFECTION DURING AN AORTIC ROOT ANEURYSM REPAIR PROCEDURE ON (B)(6) 2016. THE SURGERY OCCURRED AT MONTREAL HEART INSTITUTE. NO INFORMATION ON PRODUCT SERIAL NUMBER IS AVAILABLE. PATIENT TESTED POSITIVE FOR MNT CHIMAERA IN (B)(6) 2023 AND AGAIN IN (B)(6) 2025. NO EVIDENCE OF LABORATORY RESULTS HAVE BEEN PROVIDED. LEGAL LAWSUIT HAS BEEN ISSUED AND NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2381272	HEATER-COOLER 3T SYSTEM	CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS	DWC	LIVANOVA DEUTSCHLAND	HEATER/COOLER 3T 208V/60HZ

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown