It was reported that a homechoice cassette leaked due to a hole in the tubing.The patient was connected at the time of the event.This occurred during fill three of peritoneal dialysis therapy.The home patient (hp) saw dripping coming from the solution bag connectors.The hole in the tubing was pinhole in size, near the spike, and was small and therefore, not noticed at the time of set up.Upon noting the leak, the patient placed the clamp near the connection between the solution and cassette, closed the clamp and disconnected.The hp drained the solutes and was given prophylactic treatment (unspecified antibiotics).There was no patient injury associated with this event.No additional information is available.
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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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