Model Number 60-02-15 |
Device Problem
Partial Blockage (1065)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/03/2019 |
Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.Livanova (b)(4) manufactures the centrifugal pump system with tubing clamp.The incident occurred in (b)(6).The affected part has been requested to return to livanova (b)(4) for a detailed investigation.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.
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Event Description
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Livanova (b)(4) received a report that the shaft angle encoder of a centrifugal pump system with tubing clamp intermittently locked and did not turn during demonstration.There was no patient involvement.
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Manufacturer Narrative
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The affected parts were returned to livanova deutschland for a detailed investigation.The investigator could reproduce the reported issue.The problem could be traced to mechanical issues.Due to obsolescence of the part a new version of the encoder is used for the manufacturing of the new devices.Corrective actions are in progress for this issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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Search Alerts/Recalls
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