Model Number 10-85-00 |
Device Problem
Device Operational Issue (2914)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/01/2017 |
Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.Livanova (b)(4) manufactures the s5 double head pump.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).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 flow control knob of the s5 double head pump became stiff and hard to turn during setup.There was no patient involvement.
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Manufacturer Narrative
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A livanova field service representative was dispatched on site to investigate.During evaluation, the reported issue could be confirmed: it was caused by grime inside the flow control knob, which led to its stiffness.The field service representative cleaned the flow control knob to resolve the reported issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.
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Search Alerts/Recalls
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