Initial reporter address: (b)(6).The actual device was not available; however, photographs and a video of the sample were provided for evaluation.Visual inspection of the provided picture did not identify any abnormalities that could have contributed to the reported condition.A potential cause for the event was determined to be re-use of the single use bag.Leakage from the drain bag can occur when the bag is filled and emptied several times.Per the instructions for use provided with this device, the prismaflex sets and all the provided accessories within the sets, including the drain bags, are single use products.Once the drain bag is filled, it should be discarded and not re-used.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)¿.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.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.A nonconformance has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.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.
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