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Catalog Number 627199102 |
Device Problem
Disconnection (1171)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/17/2022 |
Event Type
malfunction
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Manufacturer Narrative
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No patient information has been provided.Livanova usa inc manufactures the complained circuit.The incident occurred in pittsburgh, pennsylvania, united states of america.Complained circuit has been discarded by the customer.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device discarded by the customer.
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Event Description
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Livanova usa inc has received a report that, during a ecls support, two different events of line disconnection occurred on the same patient with the same tubing set.The first disconnection is being reported as a separated medwatch.The second disconnection (present report) occurred on (b)(6) 2022 from a 3/8 connector that was placed in the arterial line as part of an oxygenator change-out.The connector was a competitor device.No tie bands were placed on the connection and the tubing was fully inserted over all barbs.There is no report of any patient injury.
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Event Description
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See intial report.
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Manufacturer Narrative
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Livanova received a report stating of outlet tubing disconnection during a procedure.No patient/user affected.Unit is not available.According to the technical documentation of the circuit, the involved connection is assembled by the customer.This was confirmed also through the event description details, livanova learned that the line involved was connected by the customer to the outlet of a quadrox oxy and tie banded.Indeed, the involved connection was not performed during the livanova manufacturing.The dhr review highlighted that the lot whose claimed product belong to was released as conform according to specifications.The same customer previously reported another similar event on the same.The reported disconnection can be due to a deviation in the chemical characteristics of the tubing (supplied by an external supplier) or to an improper connection made by the customer.Investigation of similar previous events did not identify any tubing significant measurable deviation nor any other specific reoccurrence that could suggest a specific root cause (no specific reoccurrence in the disconnection points, blood pressures, connection types, connections made by livanova operators or by customers).However, it could be not ruled out that untestable manufacturing and chemical deviations may have contributed to disconnection.The risk is in the acceptable region.No action is deemed necessary.Livanova will keep monitoring the market.
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Search Alerts/Recalls
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