LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
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Model Number 16-02-80 |
Device Problem
Pumping Problem (3016)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/06/2022 |
Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.The heater-cooler 16-02-80 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).The problem was caused by the stirrer motor and patient pump not working.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 the patient pump was not working.There was no patient involvement.
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Manufacturer Narrative
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A service intervention has not yet been performed on the device and is pending customer approval.Based on similar complaints investigation results, the root cause of the reported issue is most likely related to 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.
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