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

Model Number 16-02-80

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Death (1802)

Event Type  malfunction  

Manufacturer Narrative

The exact date of death was not provided.This information will be provided in a supplemental report if made available.The serial number is unknown.This information will be provided in a supplemental report if made available.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).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.Livanova (b)(4) implemented a field safety notice for disinfection and cleaning of heater-cooler devices.The z number is z-2076/2081-2015.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 customer does not know which device was used during the related procedure.Two devices were used during that period of time in which the surgery took place.It was reported that the devices were retrofitted in (b)(6) 2018 and have/were confirmed to not be contaminated at that time.There is no known device malfunction at this time, and it is unknown if the reported patient death is related in any way to the use of the heater-cooler device.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.

Event Description

Livanova (b)(4) received a report that a patient who underwent a cardiac surgery in 2011 died in 2017.It was reported that a heater-cooler system 3t was used during the procedure and that it seems that the death is associated to mycobacterium chimaera, though the exact cause of death is unknown.

Manufacturer Narrative

Through follow-up communication with the customer livanova deutschland learned that from 2017 on, the customer has cleaned the device according the instruction for use, before 2017 there is no evidence for a regular cleaning procedure.Corrective actions are in progress for this issue.

Event Description

See initial.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 7830969
• MDR Text Key: 118706329
• Report Number: 9611109-2018-01188
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 16-02-80
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2076/2081-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Death