(b)(4).The device was not returned and the lot number was unknown; therefore, a device analysis could not be completed.This complaint is for a report of a use error - reuse of single-use product during the fill stage, where the home patient stated that she changed out the cassette but did not change out the solution bags.Use errors and proper user instructions are addressed in ¿the homechoice and homechoice pro apd systems patient at-home guide¿ which is shipped with every homechoice device.It instructs the user not to attempt to reuse any disposable supplies.It warns the user that possible contamination of the fluid or fluid pathways can result if disposables are reused.A formal review of the label for the product family will be conducted.Should additional relevant information become available, a follow-up report will be submitted.
|