LIVANOVA DEUTSCHLAND ELECTRICAL VENOUS OCCLUDER (EVO); CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
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Model Number 12-80-10 |
Device Problem
Difficult to Open or Close (2921)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/19/2022 |
Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.Livanova deutschland manufactures the electrical venous occluder (evo).The incident occurred in bergen, norway.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 received report that a electrical venous occluder (evo) gave an alarm during priming.The customer did not remember the exact error code and a reportable malfunction cannot be excluded.There was no patient involvement.
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Manufacturer Narrative
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Livanova has received a report about an evo clamp returning an alarm.The perfusionist was not able to recall the error.No impact to patient.The evo was shipped to manufacturer for repair and the reported error was not confirmed.The nvmem was cleared and motor current was adjusted.Mechanical and pin point calibration were performed.Subsequent functional verification testing was completed without further issues and the unit was returned to service.A device service history review has been performed and identified that the unit was manufactured in 2018 and no other similar events have been reported.Since the issue was not reproduced, livanova believes the most probable root cause was an intermittent / temporary electrical fault, probably occurred between the encoder board and the flat ribbon cable.The risk is in the acceptable region.No corrective was deemed necessary.Livanova will keep monitoring the market.
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Event Description
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See intial report.
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Event Description
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See initial report.
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Manufacturer Narrative
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H.10: the affected device was returned back to the manufacturer site for repair.The unit was disinfected, opened, cleaned, checked and tested.The reported error was not confirmed.The nvmem was cleared and motor current was adjusted.Mechanical and pin point calibration were performed.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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