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Model Number D101 PHISIO |
Device Problem
Medical Gas Supply Problem (2985)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/02/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information were not provided.Sorin group (b)(4) manufactures the d101 dideco kids.The incident occurred in (b)(6).The involved device has been requested for return to sorin group (b)(4) for investigation.According to follow up information with the customer, based on pump data sheet, it was possible to highlight that the values of po2 = 43 mmhg and o2sat = 71%.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Not yet received.
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Event Description
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Sorin group (b)(4) has received a report that, during the administration of the cardioplegia during a procedure, a leak from the kids d101 oxygenator was observed.The 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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Livanova received a report of blood leakage in proximity to gas port of a d101 kids oxygenator.The issue was identified during procedure.Medical team elected change-out the oxygenator and no information on duration of change-out was provided.At the submission of the case, the customer provided an explicative picture of the failure showing blood leak from gas port of the oxygenator.Oxygenator was returned to livanova.Visual inspection of the device did not identify any obvious damage.To verify the integrity of the device, a leak test on blood side was performed.No leak could be reproduced.Dhr verification of the complained lot confirmed the devices was released conforming to specifications.Review of the livanova complaints database confirmed no other similar event was recorded relevant to the complained lot thus excluding a systematic issue.Livanova believes the most probable root cause of the leakage was related to damages in the oxygenator fiber bundle(s) that allowed the blood to enter the cavity of the fiber and, due to the gas flow direction, to exit in proximity to gas escape port.According to manufacturing procedures, 100% of the units are leak tested before release.The claimed unit has passed the test.Therefore, it cannot be ruled out that the damaged fibers are due to intrinsic fragility of the fibers enhanced by thermal and mechanical stresses following device release.A possible explanation on the reason why the leak was not reproduced is that the dried blood might have has plugged the cavity of the damaged fiber(s) thus sealing the fiber and making it impossible to reproduce the defect.During investigation analysis it was clarified the initial reported po2 value was related to venous blood gas analysis and therefore the reported value (43mmhg) is an acceptable value.Since the residual risk is in the acceptable region, no corrective action is 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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