LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
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Model Number 16-02-80 |
Device Problems
Insufficient Heating (1287); Temperature Problem (3022)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/14/2023 |
Event Type
malfunction
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Manufacturer Narrative
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A.1.-a.5.There was no patient involvement.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 (b)(6) united kingdom.Most likely the issue was due to refrigerant gas loss.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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Event Description
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Livanova deutschland received a report that a heater-cooler system 3t device did not cool neither patient nor cardioplegia side, even if compressor was running.The issue occurred when the machine was in service.There was no patient injury.
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Event Description
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See initial report.
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Manufacturer Narrative
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According to livanova enterprise resource planning, no service activity on-site was performed for this specific issue.The complained 3t heater cooler will be scrapped.Complaints database analysis pointed out that no other similar issue has been submitted for this unit since its installation in 2015.Based on collected information, the complained failure cannot be addressed to a specific root cause.Nevertheless, it cannot be ruled out that the root cause of the reported issue can be traced back to a faulty cooling system most likely due to the wearing.The wearing of electro-mechanical device can be originated by the specific use condition at customer site and may have contributed to the event, however there is no concerning trend for this kind of failure.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
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