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 Problem Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

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 deutschland manufactures the heater-cooler system 3t.The incident occurred in france.The article mentions 85 cases of infection with nontuberculous mycobacteria associated with healthcare and aesthetic procedures.Analysis of the article is ongoing to determine how many patient infections are reported in relation to cardiac surgery procedures and to clarify if these events have already been captured in livanova complaints database.The involvement of the heater cooler 3t was not stated clearly within the article and livanova contacted the author in order to clarify it.No answer has been received yet.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Literature review.

Event Description

Through literature review livanova became aware of an article describing nontuberculous mycobacteria (ntm) infections during 2012¿2020 associated with health care and aesthetic procedures in france.The article mentions 85 cases of infection with nontuberculous mycobacteria associated with healthcare and aesthetic procedures.

Manufacturer Narrative

H10: analysis of the article was completed: there is neither mention of livanova heater cooler 3t brand name nor its involvement in these cases of mycobacterium chimaera infection in the article.Moreover, several attempts to contact the centre, which has carried out microbiological analysis, were done without receiving answer.Based on the above, no evidence of livanova device involved allegation exists.

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; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 15606188
• MDR Text Key: 301738367
• Report Number: 9611109-2022-00519
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• 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
• Date Manufacturer Received: 03/21/2023
• 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