Model Number 10-85-00 |
Device Problem
Pumping Problem (3016)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/05/2021 |
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).Livanova initiated an 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.
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Event Description
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Livanova (b)(4) received a report that a s5 double head pump was showing a motor control failure error message during priming.The user turned off and back on the pump with no improvement.There was no patient involvement.
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Manufacturer Narrative
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H.10: the error message could be confirmed by livanova representative on site.No service activity was performed due to order replacement parts still under transit.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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See initial report.
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Search Alerts/Recalls
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