(b)(4).This is a report of use error, where there was an improper disconnection from the set.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.
|
It was reported that the patient was disconnected from the set without using proper disconnect procedures.The event occurred during the initial drain of peritoneal dialysis therapy on the homechoice.During troubleshooting, the customer tried to open the transfer set and accidentally disconnected from the set, resulting in a leak.The technical services representative assisted the customer with ending therapy and reviewed proper procedures with them.The customer completed therapy using manual supplies.There was no patient injury or medical intervention reported.No additional information is available.
|