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 04/04/2022 |
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 tested the device and could not reproduce the reported issue.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 of a electrical venous occluder (evo) giving an error message during a procedure and dashes were shown on the percentage (%) of clamp opening display of the controller.Reportedly, the display disappeared and the operation returned to normal when the mute on the system panel was pressed.There was no report of patient injury.
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Manufacturer Narrative
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Despite the issue could not be reproduced during functional check, the potentially involved components (evo processor board of the control panel and socket) will be replaced.Based on above, the most likely root cause is related to defective electronic components.
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Search Alerts/Recalls
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