LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
|
Back to Search Results |
|
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.
|
|
Search Alerts/Recalls
|
|
|