Model Number 60-05-65 |
Device Problem
Difficult to Open or Close (2921)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/07/2020 |
Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.Livanova (b)(4) manufactures the s5 erc tubing clamp / 620mm.The incident occurred in (b)(6).Livanova initiated an investigation.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 s5 erc tubing clamp / 620mm was giving an error code associated to the clamp jaw position during priming.The issue could be solved by device restarting and was used for the procedure with no further issues.There was no patient involvement.
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Manufacturer Narrative
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H.10: a livanova field service representative was dispatched to the facility to investigate the device and could not confirm the reported issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The most likely root cause of the reported error is a temporary loose connection or by the user extracting the tube.No further complaints have been received for this device/issue.
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Event Description
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See initial report.
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Search Alerts/Recalls
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