LIVANOVA DEUTSCHLAND GMBH HEATER/COOLER 3T 110V/60 HZ; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
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Model Number 16-02-85 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/08/2024 |
Event Type
malfunction
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Event Description
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Livanova deutschland has received a report that, during priming, leak was indentified under the 3t heater cooler.There was no patient involvement.
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Manufacturer Narrative
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A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in united states.A field service engeneer was dispatched to the customer site and found the complained 3t heater cooler was removed from service.Observed evidence of a leak from under the tanks.After an inspection, found the plastic "t" fitting cracked and leaking.Replaced the hoses and t fitting.Returned unit to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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Manufacturer Narrative
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H10: according to the complaints database review no other similar issue have been submitted for this unit.Based on the information collected, it cannot be ruled out that the root cause of the observed leak was related to a degradation of the external tubing t-connector which no longer allowed the seal, due to wear.
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Event Description
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See initial report.
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