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

Model Number 16-02-80

Device Problem Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Fever (1858); Weight Changes (2607); Unspecified Gastrointestinal Problem (4491)

Event Date 03/11/2015

Event Type  Death  

Manufacturer Narrative

Patient information was not provided.Serial number is unknown.This information will be provided in a supplemental report if made available.As the serial number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.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: k191402).Livanova (b)(4) implemented a field safety notice for disinfection and cleaning of heater-cooler devices.The z number is z-2076/2081-2015.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in treviso, italy.If any additional information pertinent to the reported event is received, it will be provided in the supplemental report.

Event Description

Through media monitoring process livanova became aware of a paper article on corriere del veneto (ed.Treviso e belluno) reporting that in 2015, a 63 years old male patient had undergone a surgery (repair of a heart artery that had enlarged over time and could have burst) in the cardiac surgery department of ca' foncello hospital.Seven years later the patient died.Complications related to an infection with m.Chimaera were stated as cause of the death.The first symptoms had begun to appear in 2020: fever, weight loss, and problems with the gastrointestinal system.After diagnosis confirmed, ten antibiotic tablets a day were taken by the patient to keep the infection under control.Then came the leg problems that were quickly followed by the fact that his kidneys were no longer functioning.Chimaera had slowly taken over, and on monday (likely (b)(6) 2022) the patient passed away.

Manufacturer Narrative

H10: the serial number of the device used during the procedure is unknown as well as the cleaning practice in use at the hospital at the time of the surgery.A complaints database review revealed no device contamination complaints received from this hospital in the year of the surgery (2015).Livanova contacted customer's legal office in order to retrieve additional information of the case, however no further details were made available.Based on the collected information, a direct relationship between the reported adverse event and the device cannot be excluded.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Event Description

See initial report.

Manufacturer Narrative

H10: through follow-up communication with the customer, livanova learned that: date of the surgery was (b)(6), 2015 in march 2015, the livanova installed heater coolers fleet at customer facility was the following: model 16-02-80, serial number (b)(6) and model 16-02-80, serial number (b)(6).In march 2015, routine maintenance adhering to the livanova device instruction for use was carried out at customer facility.In 2015, no nontuberculous mycobacteria (ntm) detection tests were performed before and after disinfection, since indications about it from veneto region were introduced in 2018.Patient's infection to m.Chimaera following the cardiac surgery was investigated at customer facility, according to regional council resolution n.999 of 1 2 july 2019.In the reported event, the clinical criterion was represented by the infection of the valve prosthesis, the exposure criterion was represented by the execution of an open chest surgery with recourse to extracorporeal circulation and hcu in the six years preceding the onset of the symptoms of the infection.Mycobacterium chimaera positivity was confirmed on (b)(6) 2021.Based on the information collected, there is no possibility to know which one of the two mentioned devices was involved in the surgery, however complaints database analysis revealed that no similar event was received since units installation (respectively in 2001 and 2004) and device contamination complaints were received from this customer in the year of the surgery (2015).Therefore, a direct relationship between the reported adverse event and the device cannot be established.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 15673722
• MDR Text Key: 302422233
• Report Number: 9611109-2022-00549
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2022

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
• Device Operator: Health Professional
• Device Model Number: 16-02-80
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/28/2022
• Initial Date FDA Received: 10/26/2022
• Supplement Dates Manufacturer Received: 03/02/2023; 06/23/2023
• Supplement Dates FDA Received: 03/30/2023; 07/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-2076/2081-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other
• Patient Age: 63 YR
• Patient Sex: Male