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

Model Number	HEATER/COOLER 3T 120V/60 HZ
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	12/28/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Livanova deutschland received a report in which it is alleged that a heater-cooler 3t system caused patient mycobacterium chimaera infection during a cabg procedure on (b)(6) 2018.The surgery occurred at (b)(6) hospital.The patient tested positive to mnt chimaera on (b)(6) 2025 with lab results confirmed by national jewish.
Additional Manufacturer Narrative
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 deutschland manufactures the heater-cooler system 3t.The incident occurred in the united states.Service history review did not identify any information relevant to the reported issue.The device was upgraded with vacuum and sealing kit on (b)(6) 2020 after the surgery date (on (b)(6) 2018).Through follow-up communication with the chief perfusionist under previous cases from the same hospital, livanova learned that the water in the heater-cooler systems 3t in use is changed every day and devices are stored dry.This is not in alignment with instruction for use.The devices are located inside the operating theatre during use.Legal lawsuit has been issued and no further information has been made available on this specific event.Source of patient contamination remains unknown and the livanova device involvement as well.Livanova has implemented a strategy to progressively decrease the probability of bacteria growth in the hc device by applying multiple measures implemented over the past few years through dedicated corrective actions and a field action.The risk is in the acceptable region.No other 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 80939 ; GM 80939
• Manufacturer Contact: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 24468216
• Report Number: 9611109-2026-90065
• Device Sequence Number: 16017900
• Product Code: DWC
• UDI-Device Identifier: 04033817900528
• UDI-Public: (01)04033817900528(11)170512
• 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
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 02/27/2026

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: 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: 01/29/2026
• Initial Report FDA Received Date: 02/27/2026
• Date Device Manufactured: 05/12/2017
• Usage of Device: A
• 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: Unknown