LIVANOVA USA INC DEACONESS MED SPOKANE WA 1; SMART, PERFUSION PACKS, CONNECTORS, TUBING
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Catalog Number 044033501 |
Device Problems
Disconnection (1171); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/14/2023 |
Event Type
malfunction
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Event Description
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Livanova usa has received a report that the 1/4 inch tubing on the inlet on top of the reservoir disconnected.The tube was with tie bands.There is no report of any patient injury.
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Manufacturer Narrative
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Patient information was not provided.Livanova usa inc manufactures the customized perfusion pack.Livanova initiated an investigation.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.
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Manufacturer Narrative
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Claimed part was not available for investigation, nor visual evidence of the connector was provided.Through follow-up communication, livanova learned that involved connection was the 1/4" line assembled on the suction inlet port of cardiotomy section.The failure was detected during blood collection phase.No patient injury and no additional medical intervention occurred.The same failure re-occurred with same circuit item code.Dhr review confirmed the circuit was released conforming to product specifications.Reservoir connections are 100% verified during circuit assembly and no deviation was recorded during manufacturing.The most probable root causes are: (i) an overpressure condition at the disconnection point; (ii) tubing not fully pushed on the hvr suction barb connector or (iii) moulding defect of hvr barb connector, not allowing a perfect coupling with tubing.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
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Search Alerts/Recalls
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