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Catalog Number 044026202 |
Device Problem
Disconnection (1171)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/12/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Livanova usa inc.Manufactures the convenience pack.The incident occurred in (b)(6), united states.The complained circuit was returned to livanova 30 oct 2020.A review of the dhr did not identify any deviations, non-conformities or material scrap/requests relevant to the reported issue.Based on livanova investigation, a potential root cause of the tubing disconnection could be an alteration of the chemical/mechanical characteristics of the tubings.The risk associated to the event is acceptable.No specific action is deemed necessary.Livanova will keep monitoring the market.
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Event Description
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Livanova usa inc.Has received a report that, during bypass procedure, the tubing from the outlet of the centrifugal pump into the oxygenator inlet, fell off.The medical team elected to administer blood bank to the patient.There is no report of any patient injury.
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Search Alerts/Recalls
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