Model Number 60-02-50 |
Device Problem
Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/14/2021 |
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 system with tubing clamp.The incident occurred in (b)(6).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 system with tubing clamp showed an error code and shut off during procedure.The user restarted the device which switched off again.A back up unit was used to complete the procedure.There was no report of patient injury.
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Event Description
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See initial report.
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Manufacturer Narrative
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H10: no service activity has been performed yet on the device.Based on the error code shown by the device prior shutting off and on similar complaints investigation, the most likely root cause of the reported issue is a defective eprom.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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