LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
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Model Number 16-02-80 |
Device Problems
Smoking (1585); Temperature Problem (3022)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/20/2022 |
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 and 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).A livanova field service representative was dispatched to the facility to investigate the device and found that the stirrer motor was burned out.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) to the stirrer motor on the patient side at the end of a procedure, when the device was left powered on to draw the water from the lines back to the tanks.Reportedly the device emitted smoke and smelled like something burnt.There was no report of patient injury.
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Manufacturer Narrative
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H.10: the livanova field service representative in charge replaced the stirrer motor and the issue could be solved.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The most likely root cause of the reported event is corrosion/degradation of the motor bearing, probably due to environmental conditions, which caused the stirrer motor to get stuck and the machine to use more power to work, which could have led to an overcurrent that ultimately caused the device to emit smoke and smell like a burning smell.
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Event Description
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See initial report.
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