(b)(4).The known cause of this alarm is improper disconnect.Use errors and proper user instructions are addressed in ¿the homechoice and homechoice pro systems patient at-home guide¿, which is shipped with every homechoice device.The guide provides step-by-step instructions for properly disconnecting during emergencies.Also, it provides step-by-step instructions for returning to therapy after the emergency disconnect procedure.A review of the label for the product family will be conducted.Should additional relevant information become available, a supplemental report will be submitted.
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It was reported that a homechoice device experienced a system error 2240 (air in line/set) alarm.The patient was connected at the time of the alarm.This occurred during drain one of three of peritoneal dialysis therapy.During troubleshooting, it was discovered that the patient improperly disconnected and reconnected.The technical service representative assisted with ending therapy, and reviewed proper procedures per user manual.There was no patient injury or medical intervention associated with this event.No additional information is available.
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