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

Model Number 16-02-85

Device Problems Erratic or Intermittent Display (1182); Output Problem (3005)

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

Event Date 07/10/2023

Event Type  malfunction  

Event Description

Livanova deutschland received a report that a heater-cooler system 3t device had a display malfunction during procedure: it came on and then went out, without came back on.There was no patient injury.

Manufacturer Narrative

A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in colorado springs, colorado.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.The unit was tested, upon power up the on/off switch, power was shown.However there was no display powered on or fan running.In order to fix it, service kit mains board was 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.

Manufacturer Narrative

Field service eng repair the device replacing dedicate electronic board ul507.All functional verification test completed with positive result.The device has returned to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Event Description

See initial report.

Manufacturer Narrative

H10: a complaints database review was performed and no other similar issue has been reported since unit installation in 2016.Based on livanova technical intervention, the root cause of the reported issue can be traced back to a faulty mains board, most likely due to the wearing of its electronics.

• 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: 17435449
• MDR Text Key: 320161508
• Report Number: 9611109-2023-00372
• 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,Followup
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2023
• 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
• Date Manufacturer Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2016
• 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