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

Model Number 16-02-85

Device Problem Insufficient Cooling (1130)

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

Event Date 01/03/2024

Event Type  malfunction  

Manufacturer Narrative

A.1, a.5: there was no patient involvement.H10: livanova deutschland manufactures the heater cooler system 3t.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.The unit was powered on and ran the temperatures all the way down to verify that the temperature probes were reading accurately: initially all the temperatures were around 23 degrees celsius, then after about 20 minutes the temperatures had only dropped by less than 1 degree celsius; the compressor ran for the full 20 minutes and it was extremely hot to the touch.The unit was placed into service mode to attempt to manually toggle the cooling system on and off: after running the unit for over 1 hour it was determined that the cooling system had failed and was irreparable.The unit needs therefore to be removed from 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 did not cool down to the set temperatures.The unit was turned off and back on: it was working better, however still not at right temperature.The issue occurred at setup.There was no patient involvement.

Manufacturer Narrative

H10: according to the complaints database review no further similar issues have been submitted for this unit since its installation in 2015.Based on the collected information and according to results of investigations conducted for previous similar cases, it cannot be excluded that the most likely cause of the issue could be a gas leakage at the level of the cooling unit due to degradation of cooling coil.The wearing of electro-mechanical device that can be originated by the specific use condition at customer site may have contributed to the event.

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; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 18620900
• MDR Text Key: 335411366
• Report Number: 9611109-2024-00050
• 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: 05/16/2024

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: 01/03/2024
• Initial Date FDA Received: 02/01/2024
• Supplement Dates Manufacturer Received: 04/20/2024
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2015
• 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