Model Number 60-01-35 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/19/2022 |
Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.Livanova deutschland manufactures the centrifugal pump 5 (cp5) emergency drive.The incident occurred in rionegro, colombia.The customer in not using the hlm since he's waiting for replacement of the device.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 deutschland received a report that a failure occurred during hand crank process with a cp5 emergency drive unit.Reportedly, the transmission of the movement was not possible apparently for decoupling of the wire.The customer shared photos and video of the issue showing the damage of the wire cover and stated that device was not handled badly and it was not stored in bad conditions.There was no 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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The unit was sent to the manufacturer for repair and the bowden cable has been replaced to solve the issue.All functional tests positively passed, and the unit was put back into service.Complaints database analysis revealed no similar event since unit installation in 2021.In order to prevent this issue, the ifu states that the drive shaft of the emergency unit should be stored in a horizontal position only and never be kinked.The most likely root cause of the claimed event is a rough handling by the user and/or use condition at customer site.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
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Search Alerts/Recalls
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