Model Number 60-01-04 |
Device Problem
Pumping Problem (3016)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/08/2021 |
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 5 (cp5).The incident occurred in (b)(6).A loan device was provided to the customer.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) gave a motor control failure error message during a procedure.Reportedly, there was no pump stop.The pump has run all along the surgery with the error displayed.There was no report of patient injury.
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Manufacturer Narrative
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H.10: the drive unit was returned to the manufacturer site for investigation.During functional test, no error messages / deviations were observed; the unit worked within specifications.Once the unit was disassembled for internal visual inspection on connectors and circuit boards, dust and residuals of dried fluid on the motor control board were detected.The most likely root cause of the reported issue is an intermittent failure of the motor control board.
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Event Description
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See initial report.
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Search Alerts/Recalls
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