While priming the Eurosets Adult A.L. one ECMO oxygenator (EU5019) it was noted that there was a leak from the bottom of the oxygenator. the leak appeared to originate form the seam between the fibres and the plastic housing, suspected lack of bonding. The Oxygenator was changed out during priming. A representative from the company was contacted and an inspection completed.

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Eurosets testing:

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 Gas-escape lid, refilled with water, and then pressurized.

The point of loss occurred due to the fiber breakage of the last winding at the blood outlet.

The leak reported during the priming phase can be related to a fiber rupture occurred after Eurosets manufacturing and test phases. however, further improvement processes have been implemented to reduce this occurrence.

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The safety committee have reviewed this incident and the safety report. it is acknowledged that the stringent checking by the perfusion team ensured that the leak was noted and the risk was appropriately managed. the Eurosets report outlines that they are in adherence to the appropriate controls and have met their risk matrix. However, the leak does question quality and a recognition by the community that disposable issues need to be assessed with adequate check.

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