MOD-0062 Complaint Investigation Report 106-2024.pdf

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.

Comments:

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).➢ 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).➢ IFU (Instruction For Use)The occurrence of this situation is already foreseen in our IFU. Therefore, no update is required.➢ RISK ASSESSMENT The frequency of occurrence of this situation is within of the acceptability matrix. Therefore, no update is required.❖ RISK MANAGEMENT FILETF 3 A7_3 Risk Analysis HSL FTA LIFECYCLE PRS V&V ECMO rev.05❖ HAZARDOUS SITUATION Leakage of priming solution from the device non yet connected to the patient.

Conclusions:

Thank you for your time and concern in reporting this event. We are still continuously improving our production processes and controls in order to further reduce the occurrence rate and continue to guarantee the quality and safety of our products.In case of leakages detected, Eurosets strongly recommends to carefully follow the warnings reported on the IFU: “If leakage is noticed during priming or operation, replace the defective device following good perfusion practices”.This event will be monitored within the Eurosets trend reporting and in case of adverse trends, further investigation and/or corrective actions will be carried out.