MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; 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 01/30/2024

Event Type  malfunction  

Event Description

Livanova deutschland received a report that a heater-cooler system 3t displayed an error message associated to stirring mechanism blocked or too slow.The issue occurred when the machine was in service.There was no patient injury.

Manufacturer Narrative

There was no patient involvement.H10: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in miami, florida.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.In order to solve the issue stirrer motor was replaced and also cold cardioplegia pump due to grinding noise.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.

Manufacturer Narrative

Based on device history review it can be highlighted that device was installed since 2018 and no other similar event occurred.Based on the above facts, it cannot be ruled out that the stirrer motor block was due to an advanced corrosion process inside the ball bearing.The causes leading to the corrosion, which generates irregularities on the surface of the balls, are water infiltration or water formation due to condensation or high temperatures and high levels of humidity in the stationary phase.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Event Description

See initial report.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 18797150
• MDR Text Key: 337625095
• Report Number: 9611109-2024-00107
• 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 Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/22/2024

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/28/2024
• Supplement Dates Manufacturer Received: 03/28/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2018
• 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