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Catalog Number 044064500 |
Device Problem
Disconnection (1171)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/23/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information was not provided.Livanova usa inc manufactures the complained circuit.The incident occurred in (b)(6) united states of america.The device has been received at livanova (b)(4).Initial investigation result could not reproduce the claimed disconnection.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 usa inc has received a report that, during a bypass, the quick connectors between the outlet of the revolution pump and the inlet of the oxygenator disconnected.The quick connectors were provided already tie banded.The patient was transfused with blood.
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Event Description
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See initial report.
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Manufacturer Narrative
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Livanova received a report stating that the quick connector disconnected during a procedure.The patient was transfused.The complained connection is manually done by the customer.The analysis of the livanova complaint database revealed that no other similar complaint on this circuit item code.Thus, suggesting this is an isolated event.The dhr review did not identify any issue.The complained quick connector was investigated at livanova and the reported condition could not be confirmed on the returned sample.The sample was pressurized to 15psi for six hours, a factor of safety of 1.5 to the rated 10psi of the pts pack and no disconnection or leaking was observed.The connector behaved as expected.Based on all the above facts, it cannot be ruled out that an improper connection done by the customer could have led to the reported disconnection.No device malfunction could be confirmed.Since the root cause was not identified, no specific action was deemed necessary.Livanova will keep monitoring the market.
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Search Alerts/Recalls
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