Livanova received report about decreased blood oxygenation performance, at the end of a procedure, using a d100 kids oxygenator.The complained oxygenator was not available for investigation.Verification of the manufacturing records confirmed the oxygenator was released conforming to product specifications.Analysis of livanova complaint database did not identify any other similar related to the complained oxygenator thus excluding a systematic quality issue.On november 24th, 2021, the pump sheet and blood gas analysis of the event were provided to livanova.Available data showed that, when the fio2 was raised from 60% to 75%, the patient po2 did not improved.Therefore, the complained decreased oxygenation performance has been confirmed.Differently from what stated at the submission of the event, there is no evidence in the pump sheets that fio2 was raised to 100% and no evidence that po2 were 60 mmhg.Livanova believes that the most probable explanation of the decreased oxygenation performance was the presence of shunted area across the oxygenating fibers of the oxygenator.This was likely caused by undesired cellular activation inside the oxygenator associated with platelet adhesion and fibrin layer deposition within the oxygenator, due to specific characteristics of the patient blood.Since no device related malfunction could be confirmed, no corrective action was deemed necessary.Livanova will keep monitoring the market.H3 other text : not available.
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