LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
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Model Number 16-02-85 |
Device Problem
Temperature Problem (3022)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/03/2023 |
Event Type
malfunction
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Event Description
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Livanova deutschland received a report that a heater-cooler system 3t displayed on patient side an error message associated to pump/stirring mechanism blocked or too slow, during maintenance activity.There was no patient involvement.
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Manufacturer Narrative
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H10: livanova deutschland 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 could confirm the reported issue: patient pump 1 was blocked and in order to solve the issue, it was replaced.Also the stirrer motor was replaced due to noise.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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Manufacturer Narrative
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H10: the most likely root cause of the reported issue is associated 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 conditions).This report was due on november 29, 2023; however, due to a network disruption at livanova, the ability to submit mdrs was lost on november 19, 2023, before this report was ready to submit.The report was prepared and submitted immediately following restoration of the livanova systems.
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