MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; 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 10/19/2022

Event Type  malfunction  

Event Description

Livanova deutschland received a report that the compressor of a heater-cooler system 3t stopped working when the user cooled down the cold cardioplegia and patient 2 circuits simultaneously for 30 minutes.The compressor started to cool down only the patient circuit and not the cardioplegia one, when circulation on both circuits was stopped.There was no patient injury.

Manufacturer Narrative

There was no patient involvement.The heater-cooler 16-02-80 is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k191402).Livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in new taipei city, taiwan.The compressor of a heater-cooler system 3t stopped working when the user cooled down the cold cardioplegia and patient 2 circuits simultaneously for 30 minutes.Even if temperature of the cold cardioplegia circuit arose from 4 degrees to 12 degrees and temperature of the patient circuit from 30 degrees to 33.4 degrees, compressor did not start.The compressor started to cool down only the patient circuit and not the cardioplegia one, when circulation on both circuits was stopped.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.Processor and mains boards were replaced, temperature probe was calibrated, but the the issue remains.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

H10: complaints database analysis revealed that no similar event on this device occurred since its installation in 2014.As per livanova field service representative troubleshooting, the entire cooling system needs to be reassembled; due to the reassembling, the motors and the valve block will be replaced.However, since the repair is expensive the device will be scrapped unless a specific request from the customer.Based on the information above, it cannot be ruled out that the cooling system was faulty due to wear/degradation and consequently led to the reported issue on the circuits.The wearing of electro-mechanical device can be originated by the specific use condition at customer site and 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; lindberghstr. 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: 15894305
• MDR Text Key: 305923844
• Report Number: 9611109-2022-00624
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-02-80
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2014
• 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