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

Model Number 16-02-85

Device Problems Device Alarm System (1012); Temperature Problem (3022)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/30/2021

Event Type  malfunction  

Manufacturer Narrative

There was no known patient involvement.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in united states.Livanova initiated an investigation.Livanova service engineer found the circulation motor not working and also the distribution board was not working and the cpu board was not working.Replaced all three components on system to repair the problem.Tested and put back into service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.".

Event Description

Livanova received a report about heater cooler error message on patient side.No patient involvement reported.

Manufacturer Narrative

Medical device problem code and component code have been updated since the codes included in the initial report were incorrect.Manufacturing date of the device has been added to the dedicated h.4 section.Customer information has been updated in the dedicated e section.H.10: the most likely root cause was a stirrer motor circuit board electronic fault.This led to the defect on the safety resistors on the distribution board and on the process board.

Event Description

See initial report.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich
• MDR Report Key: 12376602
• MDR Text Key: 268444576
• Report Number: 9611109-2021-00477
• 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
• Type of Report: Initial,Followup
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-02-85
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/30/2021
• Initial Date FDA Received: 08/27/2021
• Supplement Dates Manufacturer Received: 09/28/2021
• Supplement Dates FDA Received: 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1