Model Number 12-80-00 |
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 01/25/2022 |
Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.Livanova (b)(4) manufactures the electrical venous occluder (evo).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.Evo calibration and closing force update was performed and the issue improved.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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Livanova (b)(4) received a report that a electrical venous occluder (evo) could not be adjusted far enough to create pressure required when using 1/4 x 3/32 tubing and operating at low flows (~0.2lpm).There was no report of patient injury.
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Manufacturer Narrative
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H.10: the root cause of tubing not completely occluded has been traced to the fact that the set value of the closing force was not sufficient.This is a known issue and corrective action (evo motor current adjustment) is already in place.
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Event Description
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See initial report.
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Search Alerts/Recalls
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