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 Death (1802)

Event Date 12/13/2017

Event Type  Death  

Manufacturer Narrative

Pma 510(k): 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)(4) (b)(6).Through follow-up communication with the customer livanova (b)(4) learned that the patient death was not attributed to the infection.Moreover, it was reported 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.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 heater-cooler 3t system is the source for the claimed patient infection.A review of the dhr did not identify any deviation 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 a valve replacement on (b)(6) 2017 got infected with some species of mycobacterium.It was reported that a heater-cooler system 3t was used during the procedure.The patient went to the (b)(6) and was transferred to the (b)(6) on (b)(6) 2017 for endocarditis suspicion.The patient was in poor health condition.The patient suffered a dyspnea since several month.Further testing revealed an aortic leak on peri and intra, global cardiac decompensation, abscess aspect and pleural effusion.On (b)(6) 2017 the patient underwent an additional valve replacement procedure.His heart was very slow and therefore a pacemaker was used.The patient developed a pericardic hematoma, pleural effusions and very degradated respiratory function.On (b)(6) 2019 livanova (b)(4) received the information that after three cardiac arrests the patient died on (b)(6) in 2017.

Manufacturer Narrative

In previous report is stating the (b)(6) 2017 as event date.In that date, the clinic reported to livanova the infection on 5 patients.Please note the following related to the patient case reported in this report: on (b)(6) 2016 the patient underwent rvao procedure, on (b)(6) 2017 the patient was hospitalized with suspicion of endocarditis, on (b)(6) 2017 the valve was replaced and there was no evidence of contamination of the implant.In previous report states "on (b)(6) 2019 livanova (b)(4) received the information.".Please note the corrected date: "on (b)(6) 2018 livanova (b)(4) received the information." in previous report, it was stated 29th of december 2017.Date received by manufacturer is 13th of december 2017.Which is the date when livanova (b)(4) has been informed on the issue.New data on (b)(6) 2018 livanova (b)(4) received confirmation of presence of unspecified ntm in patient´s samples.

• 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: 7220931
• MDR Text Key: 98275265
• Report Number: 9611109-2018-00073
• 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,Followup
• Report Date: 10/25/2018

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
• Device Operator: Health Professional
• Device Model Number: 16-02-80
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2018
• 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): Death
• Patient Age: 81 YR