LIVANOVA USA INC COBE SMARXT TUBING AND CONNECTORS; TUBING, PUMP, CARDIOPULMONARY BYPASS
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Catalog Number 627336403 |
Device Problem
Disconnection (1171)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/02/2022 |
Event Type
malfunction
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Event Description
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Livanova usa received a report that during an ecmo procedure, a 3/8 connector disconnected.The technician caught the incident before any impact to patient.There is no report of any patient injury.
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Manufacturer Narrative
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Sorin group italia manufactures the smart perfusion pack.The incident occurred in (b)(6).During follow up with the customer, livanova was informed that: the disconnection occurred about 30 min after putting the patient on the ecmo circuit.The nurse was able to catch the connector that disconnected, reattached it the tubing and re-tie-banded the connection on both sides.No issue to patient has been reported.During priming, no leak was not noticed.The complained pack is not available since patient still on the circuit livanova representative recommended to check all connections during priming.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.Patient still on the circuit.
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Manufacturer Narrative
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Livanova received a report stating that about 30 minutes after putting the patient on the ecmo circuit, the tubing just slipped back off the 3/8 connector and failed where the tie band was attached.The nurse was able to catch it and reattach the tubing and re-tie band immediately on both sides and the issue caused minor blood.The patient was fine.During priming no leak was noticed.Picture of the issue was received, confirming it.Pack is not available because the patient is still on the circuit.The dhr review highlighted that the lot whose claimed product belong to was released as conform according to specifications.By reviewing the complaints database, another similar event for tubing disconnection related to this connector has been recorded on the same pts pack code, but different lot number.According to technical documentation, the involved 3/8 connector is assembled with the tubing through the use of solvent and then tie banded.According to instruction, this circuit is not released for ecmo use.Based on above and without sample to analyze, it cannot be ruled out that the disconnection was due to the following possible root causes: insufficient presence of solvent; tie band not tight enough; tubing and/or connector dimensional issue.The risk is in the acceptable region.Livanova will keep monitoring the market.
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Event Description
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See initial report.
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Search Alerts/Recalls
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