It was reported during continuous veno-venous hemodiafiltration treatment with a prismaflex hf1400 set, an external leak at the syringe connection and the top of the filter connection was observed shortly after connecting the patient.This resulted in an unknown amount of blood loss.A blood return was attempted, and the filter set was changed.There was no patient injury, or medical intervention associated with this event.No additional information is available.
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H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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