Model Number 60-02-60 |
Device Problem
Pumping Problem (3016)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/12/2020 |
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 5 (cp5).The incident occurred in (b)(6).Through follow-up communication livanova learned that when he turned the knob the rpms would only go up to 1200.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 that a centrifugal pump 5 (cp5) had a shaft angle encoder fault during priming and the pump speed could not be controlled.The device was replaced with another one.There was no patient involvement.
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Event Description
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See initial report.
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Manufacturer Narrative
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H.10: the customer was provided with a new control panel.The most likely root cause of the issue is a defective shaft encoder.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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