Additional information added to d9, h3, h6 and h10 the device was received for evaluation.Visual inspection showed the product was contaminated.After the disinfection of the product, a leakage test of the dialysate side was performed and a leakage was observed.The cause of the leakage is a crack in the housing at the position of the hansen connector.A stress mark on two sides of the dialysis connector can be seen.The reported issue was confirmed.As the stress mark is on the side of the dialysate port, it can be assumed that the damage did not occur during the production of the product.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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