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

Model Number 16-02-80

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Endocarditis (1834)

Event Date 12/13/2017

Event Type  Injury  

Manufacturer Narrative

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).Through follow-up communication with the customer, livanova (b)(4) learned that the heater-cooler system 3t was positioned inside the operation theater approximately 2 meters away from the operation table.In addition it was reported that the heater-cooler was cleaned according to the instructions for use.The reported infection of the patient could be confirmed but the species of the bacteria could not be identified due to the antibiotic therapy.Water samples of the heater-cooler system 3t were taken and no contamination was found.As the mycobacteria type associated to the infection identified in the patient is not known, and no contamination has been identified in the 3t heater-cooler used during the open heart surgery, livanova (b)(4) has no elements to state that the 3t device is the source for the claimed patient infection.A review of the dhr did not identify any deviations or non-conformity relevant to the reported issue.If further information pertinent to this case will be received, they will be provided in a supplemental report.Device was not returned.

Event Description

Livanova (b)(4) received a report that a patient which underwent an aortic valve replacement on (b)(6) 2016 got infected with some species of mycobacterium.It was reported that a heater-cooler system 3t was used during the procedure.The patient returned to the hospital on (b)(6) 2017 with endocarditis.The patient received antibiotics and underwent an additional surgery on (b)(6) 2017.After the surgery the patient received an additional antibiotic therapy.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 7220932
• MDR Text Key: 98278810
• Report Number: 9611109-2018-00071
• 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: other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2018
• 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?: No
• Date Manufacturer Received: 12/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 61 YR