SORIN GROUP ITALIA D100 NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS,
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Catalog Number 050531 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/30/2023 |
Event Type
malfunction
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Event Description
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Sorin group italia has received a report that, after 10 minuntes from initiation of cardiopulmonay bypass, the kids d100 neonatal oxygenator was leaking.Medical team elected to change out the oxygenator.There is no report of any patient injury.
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Manufacturer Narrative
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A.1.-a.5.Patient information were not provided.H.10.Livanova manufactures thekids d100 neonatal oxygenator.The incident occurred in india.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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Manufacturer Narrative
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No further information could be retrieved from customer, regarding change out duration, phase of the procedure during which item was replaced (before/during cross clamp), precise leakage area indication (junction point between blood outlet port and threaded luer port where temperature probe is screwed / gas outlet port).Moreover, no pictures were shared and no confirmation of item availability was provided.Verification of manufacturing records pointed out that noticed device was released as conform according to specifications.Analysis of complaints database revealed one other event associated to the same oxygenator lot.That event was of leak from the gas outlet port of the oxygenator.This type of leak is cause by damaged capillary in the fiber bundle of the oxygenator module.During manufacturing, 100% of the oxygenators are subjected to final leak test and the involved oxygenator successfully passed the in-process check.No trend has been registered for similar case.Bases on all the above, it cannot be excluded that the complained leak was a damaged fiber and fiber bundle capillary manufacturing variability with contribution of thermal and/or transportation mechanical stress could have led to breakage during use.The risk is in the acceptable region.No specific action was currently deemed necessary.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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