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); Hearing Impairment (1881)

Event Type  Injury  

Manufacturer Narrative

A.1.-a.5.Patient information was not provided.D.4.Serial number is unknown.This information will be provided in a supplemental report if made available.H.4.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.G.5.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).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.H10: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in zwolle, netherlands.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova deutschland received a report that, at the end of 2022, a patient became ill due to a bacteria on the heart valve.After a culture of bacteria, it turned out to be the mycobacterium chimaera.This patient underwent heart surgery in 2013, using the heater-cooler system 3t.The patient is now doing better.However, due to treatment of the bacteria, the patient is permanently hearing impaired on one side.

Manufacturer Narrative

Through follow up, livanova was informed that the patient is reporting hearing problems that the patient suffered allegedly due to medication that was used in relation to the bacterial infection (mycobacterium chimaera) and subsequent problems with one of more heart valves.However, no direct causal link between the use of the heater cooler during a medical operation in 2013 and the occurrence of the bacterial infection which was discovered in 2022 cannot be established.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

• 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 GMBH; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 17753887
• MDR Text Key: 323466611
• Report Number: 9611109-2023-00441
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/30/2024

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: 08/18/2023
• Initial Date FDA Received: 09/15/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Other
• Patient Sex: Female