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

Model Number 16-02-80

Device Problem Temperature Problem (3022)

Patient Problem No Patient Involvement (2645)

Event Date 11/24/2020

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: k191402).Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Livanova field service representative dispatched to the facility confirmed the reported issue.In order to solve it, the stirrer motor was replaced.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The most likely root cause of the reported event is the corrosion of the degradation of the stirrer motor bearing due to environmental conditions in which the motor worked.In detail,condensation or high temperatures and high level of humidity in the stationary phase led to rust formation preventing the motor from rotating.

Event Description

Livanova (b)(4) received a report that a heater-cooler system 3t displayed an error message associated to the stirrer motor at the start-up.There was no patient involvement.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80309 ; GM 80309
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada 80004
• MDR Report Key: 11051048
• MDR Text Key: 223764041
• Report Number: 9611109-2020-00706
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: No
• 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: 11/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2017
• 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