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

Model Number 16-02-80

Device Problem Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Date 12/17/2019

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.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: k052601).Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device.He could not confirm the reported smoke.However, as soon as the unit was started, the mains supply was tripped.The technician traced the failure back to a defective compressor.The smoke could be generated from the interaction of the coolant and the chemicals used for the routine cleaning of the device.The root cause could be a hole in the evaporator causing leak of coolant and water entering the refrigeration cycle and thus damaging the compressor.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 some smoke was coming out from the water inlet of a heater-cooler system 3t during routine cleaning.There was no burning smell.When the user attempted to further fill the device, more smoke came out thus the user stopped the cleaning.There was no report of patient/user injury.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA, INC.; 14401 w. 65th way; arvada 80004 ; GM 80004
• 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: 9590600
• MDR Text Key: 175027900
• Report Number: 9611109-2020-00021
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Other
• Type of Report: Initial
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this a Product Problem Report?: Yes
• 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: 12/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2013
• 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