Model Number 16-02-85 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/17/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in atlanta, georgia.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue: there was a small pool of water gathering under the device; the unit was removed from service by the customer.The leak was coming from the cardiopelgia bottom blue tubing on the back panel of the unit.Therefore, in order to solve it the involved blue tubing was disconnected and re-seated.Subsequent functional verification testing was completed without further issues and the unit was returned to service.
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Event Description
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Livanova deutschland received a report that an external water leak from cardioplegia side of a heater-cooler system 3t was observed during procedure.There was no patient injury.
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Manufacturer Narrative
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Complaints database analysis revealed no similar event since unit installation in 2017.Based on the above facts and because the disconnected tube is not accesible by the user, it cannot be ruled out that the reported event was caused by an accidental error during previous service activity.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
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Search Alerts/Recalls
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