Model Number 60-01-04 |
Device Problem
Pumping Stopped (1503)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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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).A technician investigated the device and was not able to reproduce the reported failure.Investigation is still ongoing.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 during operation a centrifugal pump 5 (cp5) drive unit stopped working and the control panel became black.The user switched over to the emergency drive.There was no report of patient injury.
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Manufacturer Narrative
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H.10: the drive unit and the control panel were requested at the manufacturer site for further investigation.No deviation could be identified.The device has been returned back into service.Based on the fact that no malfunction and no defect could be identified, an hardware failure of the device can be ruled out and the reported event is therefore re-assessed as non reportable.
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Event Description
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See initial report.
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Search Alerts/Recalls
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