One av line including an adult arterial filter was returned to livanova usa for evaluation.The outlet port of the filter was confirmed to be broken off flush with the base of the port.The attached tubing was not pushed all the way on and there was no whitening of the plastic.The break appeared to be a clean and sharp.All product incorporated within the livanova usa pts tubing packs are closely and carefully inspected during assembly and pack-out, and the heart lung pack tray is specifically designed to protect the contents during routine shipping and handling stresses.Additionally, symbols are clearly placed on the over-shipper, indicating that the contents are delicate medical product.This broken port indicates rough handling after release from livanova.In an effort to further address this issue, the print drawing for this 065254600 catalog number was updated with additional photographs to clarify the proper placement of the arterial filter and its saddle within the pack to afford optimum protection to the component during transport.This lot number was for a total build of forty (40) packs and this is the only complaint received against this lot number.The damage to this product occurred after release from livanova.
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