Model Number 10-80-00 |
Device Problem
Unexpected Shutdown (4019)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/11/2019 |
Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(4).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 of a s5 roller pump shutdown during priming.The pump was replaced with a backup device.There was no patient involvement.
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Manufacturer Narrative
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H.10: no additional information about service activity performed on this specific device has been provided to livanova.However, this type of issue is mostly related to electric/electronic defective components of the pump itself and to communication failure between pump circuit boards.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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Event Description
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See initial report.
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Manufacturer Narrative
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The serial read out of the affected pump was analyzed and the roller pump was further investigated.It was confirmed that the pump is unable to boot.Considering the age of the pump, it cannot be ruled out that he reported event was most likely caused by a computer board failure.
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Search Alerts/Recalls
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