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

Model Number 16-02-80

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

There was no known patient involvement. The heater-cooler 16-02-80 is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k052601). Livanova (b)(4) manufactures the heater-cooler system 3t. The incident occurred in (b)(6). Livanova (b)(4) initiated an investigation. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova (b)(4) received a report that a heater-cooler system 3t device was found to be contaminated with mycobacterium chimaera. There was no known patient involvement.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 9361052
• MDR Text Key: 196155024
• Report Number: 9611109-2019-00908
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Notification
• Type of Report: Initial,Followup
• Report Date: 12/24/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 16-02-80
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 11/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2017
• 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