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Complaint Investigation:

We checked the production documentation related to the claimed lot and we confirm that all tests made in the production process were compliant with the technical specification. We confirm that we apply the 100% production process test to all our devices.

The device returned to Eurosets for technical investigation.

We set-up the circuit: the reservoir is filled with 500 ml of physiological water; the oxygenator module is filled form the reservoir using a peristaltic pump (Q = 6 l/min) and remained in loop for 10 minutes.

We notice a slow dripping in the lower part of the oxygenator, in front of the arterial blood out.

To identify the exact point of leakage, the device was sectioned removing the lower lid, refilled with water, and then pressurized.

The point of loss occurred due to the fiber breakage.

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The leak reported during the priming phase can be related to a fiber rupture occurred after Eurosets manufacturing and test phases.

Eurosets oxygenators are all undergoing multiple leakage tests during production and devices that exhibit leaks are discarded prior to distribution.

The device history record was duly reviewed; devices are required to pass manufacturing inspections and specifications prior to release and no abnormalities were documented which would cause or contribute to the reported occurrence. This device passed all required testing.

Our production and post-production tests are severe and strict, and 100% of the Oxygenators produced are tested to detect eventual leakages using a pressure of 150 kPa. (1.5 time the maximum blood pathway pressure indicated on the IFU).

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CAPA (Corrective Action/Preventive Action)

After thoughtful and deep investigation on possible improvement processes, we implemented a series of additional, specific, controls and manufacturing changes. After these changes, we were able to reduce the occurrence of this issue (<1 case every 2.000 ECMO oxygenators used).

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IFU (Instruction For Use)

The occurrence of this situation is already foreseen in our IFU. Therefore, no update is required.

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RISK ASSESSMENT

The frequency of occurrence of this situation is within of the acceptability matrix. Therefore, no update is required.

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