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

Model Number 16-02-95

Device Problem Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.The heater-cooler 16-02-95 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 initiated an investigation.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 a heater-cooler system 3t displayed an error message during procedure.The side affected is unknown.A stirrer motor malfunction can't be excluded.Reportedly, the procedure was completed by a back up device.There was no report of patient injury.

Manufacturer Narrative

H.10: a livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue and found out that the stirrer motor was blocked.The stirrer motor was replaced and the problem solved.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 was the corrosion of the motor bearing due to condensation or high temperatures and high level of humidity in the stationary phase which led to the motor shaft blockage.

Event Description

See initial report.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 11065227
• MDR Text Key: 223434568
• Report Number: 9611109-2020-00714
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-02-95
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1