Initial reporter address: (b)(6).Prismaflex st100 set c has been temporarily approved for use in the us under emergency use authorization (b)(4) to deliver crrt to treat patients in an acute care environment during the covid-19 pandemic.The actual sample was not provided for evaluation; however, a picture was provided.The reported condition was verified.The cause is user error.This issue is being further investigated.The customer reported that an external fluid leakage from the drain bag occurred 2-3hours after treatment started.All accessories provided within the set, including drain bag, are single use products.This means that once used, the drain bag must not be reused (i.E.Emptied and reused during the same therapy) and should be discarded.However, the prismaflex control unit operator's manual indicates to ¿change fluid bags when the appropriate caution alarm occurs (pbp bag empty, replacement bag empty, dialysate bag empty or effluent bag full)¿.Furthermore, the prismaflex control unit warns the operator when the effluent bag is full and it is specified in the on-screen instruction delivered by the prismaflex control unit that the drain bag should be disconnected and changed for a new bag.Should additional relevant information become available, a supplemental report will be submitted.
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