MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH HEATER COOLER 3T (230 VOLT); CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 16-02-80

Device Problem Insufficient Cooling (1130)

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

Event Date 10/13/2023

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.Patient information was not provided.G.5.The heater-cooler 16-02-80 is not distributed in the usa and it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k191402).H10: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in uk.A livanova fi eld service engineer was dispatched tothe customer site and the issue could be confi rmed.When the compressor activates, there is a loud noise indicating low gas.Also, when setting the temperature on warm, cold and patient tanks to cool down.This unit did not function and when turned off there is a hissing noise coming from the plegia tanks.Unit shall not be used until repaired.A followup report will be provided no later than (b)(6) 2024.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova deutschland has received a report that a 3t heater cooler was not cooling during a procedure.There is no report of any patient injury.

Manufacturer Narrative

H10: a device service history review has been performed and identified that the unit was manufactured in 2015 and no other similar event has been reported.The unit will not be repaired and it was replaced with a new one.Based on the information collected, the most likely root cause of the reported issue could be traced back to a degradation of cooling coil (coil micro-hole formation) leading to refrigerant leak.The erosion kit upgrade was already installed on the device in 2019 and includes the new design of the pump head of the stirrer motor to prevent a water flow directed to a narrow area of the evaporator coil.The issue was claimed about more than 4 years after the upgrade which suggests that the issue is most probably caused by the corrosion and not erosion and occurred overtime independently from the upgrade.

Event Description

See initial report.

• Brand Name: HEATER COOLER 3T (230 VOLT)
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; 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: 18138026
• MDR Text Key: 328123775
• Report Number: 9611109-2023-00605
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 01/30/2024

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: 16-02-80
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 11/15/2023
• Supplement Dates Manufacturer Received: 01/23/2024
• Supplement Dates FDA Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1