Sorin group (b)(4) has received a report that, 30 minutes after the begin of the procedure, the values of the transmembrane pressure of the inspire oxygenator were high.The medical team elected to change out the oxygenator.After the change out, the values of the transmembrane pressure back to normal.Livanova has been informed the patient has died on the same date (b)(6) 2020).The medical team does not believe there is any correlation between the event and patient demise.
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The pump-sheet of the case was not provided, however, during follow-up activity, it was pointed out that blood coagulation had developed in the system.The biological deposits reasonably caused the partial occlusion of filtering elements thus reducing the open surface for blood flow and leading to increase of the pressure drop across the oxygenator.No further similar complaints were recorded for noticed product lot.Manufacturing records were verified to be conforming to specifications.According to historical data analysis, the high transmembrane oxygenator pressure gradient is related to the increase of hydraulic resistance as a result of undesired cellular activation associated with platelet adhesion and fibrin layer deposition inside the oxygenator.This type of event is a multi-factorial phenomenon possibly triggered by a combination of clinical procedure, therapies (e.G.Anticoagulant prescription, heparin composition and priming composition) and patient-specific health conditions.Based on collected evidences, the claimed high pressure excursion was confirmed and assigned to reported activation of clotting phenomenon throughout the circuit.No specific action was currently deemed necessary.Livanova maintains and documents periodic customer events monitoring process in order to evaluate actions for products improvement.The likelihood of occurrence of complained failure is acceptable.Livanova will keep monitoring the market.
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