It was reported that after starting therapeutic plasma exchange (tpe) treatment using four prismaflex tpe sets, clotting siting ¿access issues¿ was observed.It was reported that access was intact and patent.It was reported treatment was started with -50 to -80 and after five to ten minutes, the access would jump to over -250.Treatment was discontinued, and the extracorporeal (ec) blood was returned to the patient after the first event; however, it was unknown if the ec blood was returned for the subsequent events.It was reported a new tpe2000 was prepared; however, the event occurred again with "one to two filter sets".A tpe2000 set with a different lot number was then prepared and treatment was successfully completed.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
|
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.
|