LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
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Model Number 16-02-80 |
Device Problem
Insufficient Cooling (1130)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/17/2021 |
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 could confirm the reported issue.The failure was traced back to a defective cooling compressor.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 did not cool during service.There was no report of patient injury.
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Event Description
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See initial report.
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Manufacturer Narrative
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A device service history review has been performed and identified that the unit was manufactured in 2014 as well and no other similar events have been reported.Taking into account the information above, the involved equipment is going to be scrapped.The reported event is addressed by capa 2017-07 (degradation hc3t) and rci 2016-36 (leakage evaporator).Based on findings, a potential breach of the cooling coil can be generated due to stirrer flow in the tank.Consequently, the water will enter the cooling circuit and the compressor unit.This potential failure mode will cause immediate damage of the cooling compressor system.The compressor failure leads to an increase of the leakage current of the device and the circuit breaker will trip.On (b)(6) 2021 it was performed the erosion kit upgrade (#005-21-0061) according to the fco_2017-001 (retrofit / vacuum upgrade of livanova hc-3t - erosion kit) of the devices that includes the new design of the pump head of the stirrer motor to prevent a water flow directed to a narrow area of the evaporator coil.The issue was claimed 2 months after the upgrade and most probably the condition of the evaporator was already compromised before the upgrade to such an extent that the copper was rather degraded.No other specific action was currently deemed necessary, livanova maintains and document periodic customer events monitoring process in order to evaluate actions for products improvement.
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