Model Number 60-05-00 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/19/2018 |
Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.Livanova (b)(4) manufactures the s3 erc tubing clamp/ 620mm.The incident occurred in (b)(6).Livanova (b)(4) requested the part back for further 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 s3 erc tubing clamp displayed error messages during servicing.There was no patient involvement.
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Manufacturer Narrative
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The defective device was returned to livanova deutschland for further investigation.During the evaluation the reported issue could be reproduced.As root cause, fluid ingress inside the device could be determined.Livanova deutschland implemented a corrective action for the reported issue.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.
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Event Description
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See initial.
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Search Alerts/Recalls
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