MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND HEATER/COOLER 3T 110V/60 HZ; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 16-02-85

Device Problem Temperature Problem (3022)

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

Event Date 12/02/2022

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.Livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in united states.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue: errore 6 at patient side and circulator motor was not functioning.The circulator motor em109, erosion kit and processor board were replaced.Subsequent functional verification testing was completed without further issues and the unit was returned to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova deutschland received a report that a heater-cooler system 3t displayed an error message (error 6) associated to the stirrer motor of patient pump during a procedure.There is not report of any patient injury.

Event Description

See initial report.

Manufacturer Narrative

B.5.The event occurred while cleaning and disinfecting the device and it did not occured during procedure as previously communicated.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

H10: most likely root cause of the reported event could be traced back to motor bearing damaged by the corrosion, which consequently does not allow the motor shaft to rotate freely.Possible causes are water infiltration or water formation due to condensation or high temperatures and high level of humidity in the stationary phase.Causes related to environmental conditions.The malfunction of the stirring motor led to damage also the processor board.

• Brand Name: HEATER/COOLER 3T 110V/60 HZ
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 16076517
• MDR Text Key: 308492753
• Report Number: 9611109-2022-00696
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/09/2023

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 Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 12/30/2022
• Supplement Dates Manufacturer Received: 12/12/2022; 03/31/2023
• Supplement Dates FDA Received: 01/11/2023; 04/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2020
• 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