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Catalog Number 044035103 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/22/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The involved cardioplegia line was returned to livanova for further investigation.Plugs were present at all line ends to retain fluid still in the lines.Visual inspection confirmed that debris was present in the line.The debris, which appears to be metal with jagged edges and curled ends, was found floating in the bubble trap.All other remaining components were inspected and no additional debris was found.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.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 received a report that a metal shaving was observed in the post-heat-exchanger-coil cardioplegia tubing of the custom perfusion tubing set.This was discovered during a procedure.The shaving made its way to the rdc and stayed there.The customer opened a new pack and set up a new cardioplegia circuit to continue the procedure.There was no report of patient injury.
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Manufacturer Narrative
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This coil is supplied to livanova by an outside supplier.A supplier quality notification was initiated to investigate this issue.Investigation connected with this event verified that, while the metal flake was determined to have come out of the coil during the procedure, it did not originate from the coil itself and is believed to have been deposited during one of the manufacturing processes.The root cause of this failure has been determined to be due to a defect in the supplier's manufacturing process.Livanova has implemented a change order to run air through all coils received to ensure that they are free of any debris prior to consumption into a perfusion pack.Additionally, livanova has initiated a capa to investigate this issue further.
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Search Alerts/Recalls
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