Model Number 60-02-50 |
Device Problems
Inaccurate Flow Rate (1249); Improper Flow or Infusion (2954)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/09/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Livanova (b)(4) manufactures the centrifugal pump system with tubing clamp.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate.The service representative was able to confirm the reported issue and traced the failure to a defective display panel.The technician replaced the panel to resolve the reported issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.
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Event Description
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Livanova (b)(4) received a report that a centrifugal pump system with tubing clamp could not zero the flow and did not show the correct flow amount intermittently during procedure.Patient information was not provided.
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Manufacturer Narrative
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The replaced device was returned to livanova (b)(4) for further investigation.During evaluation, the reported issue could be confirmed.The root cause for the reported issue was identified to be a faulty flow board.The customer has requested that the device not be repaired and the unit was scrapped.
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Search Alerts/Recalls
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