Correction made to b3/d10: the events occurred on an unspecified date in (b)(6) 2024, reported as "over the past week." correction made to d10: amia cassette (previously reported as homechoice cassette).B5: the patient would cut the transfer set from the cycler cassette and the nurse would change the transfer set.H10: two (2) actual devices were returned for evaluation with patient connectors attached to the female connectors.A visual inspection with the naked eye noted a separation between the female connector and main body.Functional testing including leak, clear passage, and clamp function testing were performed with no issues noted.The patient connectors were connected and disconnected from the female connectors by hand with no issues observed.The reported connection issue was not verified.The cause of the separation was related to inadequate solvent application between the female connector, insert chip, and main body during the manufacturing process.A batch review was conducted and there were no deviations found related to this condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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