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 11/11/2022

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in united states.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 5) associated to the temperarature problem and stirrer motor during maintenance.In addition, foam was out of the tap overfolow.There was no patient involvement.

Event Description

See initial report.

Manufacturer Narrative

H10: no service activity has been scheduled yet for this device.However, based on investigation results of previous similar cases, the reported error is related to a too-low power consumption of the pump motor, therefore most likely it did not work correctly.Complaints database analysis revealed that no similar event on this device occurred since its installation in 2013.As the event is isolated and the pumps have never been changed, it cannot be excluded that an electro-mechanical defect has led to the displayed error.Based on the fact that it was noted foaming out of overflow (useful for collecting excess water), it cannot be ruled out that another contributing root cause could be related to excessive water in the tanks reaching internal circuits and damaging the impacted pump motor.If any additional information pertinent to the reported event is received, it will be provided in a supplemental 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; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 15948384
• MDR Text Key: 306898728
• Report Number: 9611109-2022-00643
• 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
• Report Date: 12/07/2022

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/11/2022
• Initial Date FDA Received: 12/09/2022
• Supplement Dates Manufacturer Received: 03/31/2023
• Supplement Dates FDA Received: 04/28/2023
• Date Device Manufactured: 07/23/2013
• 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