Address: (b)(6).Prismaflex st100 set ckt 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.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.However, it is to be noted that the prismaflex st100 set ckt set and all the accessories provided within the set, including the drain bag, is a single use product and should be discarded after use.During the investigation of similar complaints, it has been noticed that the leakage on the drain bags occurred mainly after several hours of treatment, after being filled and emptied several times.The filling/emptying cycles generates physical constraints on the bags, near the welding of the exhausting tube, eventually causing pinholes to form and leakage to happen.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.Only one bag is provided within the sets since this bag is the one needed to prime the set and to start therapy.Since therapy duration and prescribed doses vary for each patient and therapy, replacement bags are provided by baxter as spare bags.Based on the above, the cause identified for the reported event is a user error of the effluent bag.A nonconformance has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.
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