Model Number 16-02-95 |
Device Problem
Temperature Problem (3022)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/28/2021 |
Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.The heater-cooler 16-02-95 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 (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).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 (b)(4) received a report that a heater-cooler system 3t displayed an error message associated to the stirrer motor during priming and was not improved despite turning off/on the device.There was no patient involvement.
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Manufacturer Narrative
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H10: a livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.The patient bridge was replaced.Subsequent functional verification testing was completed without further issues and the unit was returned 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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Event Description
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See initial report.
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Event Description
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See initial report.
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Manufacturer Narrative
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H.10: the issue is more likely associated to the motor bearing damaged by the corrosion, which consequently does not allow the motor shaft to rotate.Possible causes are water infiltration or water formation due to condensation or high temperatures and high level of humidity in the stationary phase.Causes related to environmental conditions.
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Search Alerts/Recalls
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