LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
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Model Number 16-02-80 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/24/2022 |
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).The power cable has been ordered and will be replaced.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 the plug of the power cable of a heater-cooler system 3t is showing signs of smoldering and need to be replaced.There was no patient injury.
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Manufacturer Narrative
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H10: complaints database analysis revealed that another similar event on this heater cooler 3t system occurred since its installation in 2017.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 damaged plug of the power cable that was replaced.Moreover, since the wire sleeve of the cable did not fit into the block clamp of the device, also this item was replaced.Subsequent functional verification testing was completed without further issues and the unit was returned to service.A picture of the plug was provided and showed black marks on the plug pins which may occur in case the power plug is not plugged directly into the wall socket and adapters/multi-plug sockets are used.Interposing a multiple socket could result in an overheating due to the passage of high current and to the reported black marks.This situation may happen also if the plug connectors for the power cable and the mains plug are not completely dry and inserted in the wall socket.Therefore, most likely root cause was a defective/inadequate hospital wall socket.
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Event Description
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See initial report.
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