LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
|
Back to Search Results |
|
Model Number 16-02-80 |
Device Problem
Electrical Shorting (2926)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/11/2023 |
Event Type
malfunction
|
Event Description
|
Livanova deutschland received a report that a heater-cooler system 3t cut off electrical network of the operating room when the cooling unit started up.The issue occurred post-procedure.There was no patient involvement.
|
|
Manufacturer Narrative
|
There was no patient involvement.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).Livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in (b)(6) france.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
|
|
Manufacturer Narrative
|
Complaints database analysis also revealed that no similar event since unit installation in 2011.The reported event is a known issue.Based on the findings, a potential breach of the cooling coil can be generated due to stirrer flow in the tank.Consequently, the water will enter the cooling circuit and the compressor unit.This potential failure mode will cause immediate damage of the cooling compressor system.The compressor failure leads to an increase of the leakage current of the device and the circuit breaker will trip.In 2020, the device was upgraded including a newly designed 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 3 years after the upgrade, but most probably the condition of the evaporator was already compromised before the upgrade to such an extent that the copper was rather degraded.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
|
|
Event Description
|
See initial report.
|
|
Search Alerts/Recalls
|
|
|