LIVANOVA USA INC AORTIC ARCH CANNULAS; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
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Model Number RA-XXXXX |
Device Problem
Disconnection (1171)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/14/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information was not provided.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Follow up with the customer clarified the patient was not affected, no bleeding was reported, and the complained cannula is available.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.
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Event Description
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Livanova usa inc has received a report that the tip of the aortic disconnected from the body of the cannula at the end of a surgery there is no report of any 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 dhr review highlighted that the lot whose claimed product belong to was released as conform according to specifications.The complaints history was reviewed, and no similar event was identified related to the same lot.The involved unit was returned to the manufacturer's site according to standard operating procedure, uv adhesive shall be applied to the inside surface of the cannula's distal end and the bonding surface of the curved tip.Visual inspection of the returned cannula found no uv adhesive ring present at the end of the tip.When the tip was pulled out, there appeared to be no adhesive at all.The most probable root cause of the disconnection was a manufacturing error.The manufacturing personnel will be involved in a dedicated training the risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
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