H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Samples received: the samples consist of four (4) cassette from p/n 21-7302-24 l/n 4037752; the returned samples were received two in used conditions without its original package and received two with its original closed package.Visual inspection results: the samples do not present any damage, scuffs, pinch marks, cracks, crazing, cuts, etc.Could cause the failure mode reported.Functional testing: after performed the leak testing the samples were fill whit colored water using a syringe in order to detect any leakage.Results: the samples 3 and 4 present leak in the join with the tube of the bag, therefore it is confirmed the failure mode reported.The complaint is confirmed.The cause of the reported problem was traced to the manufacturing process.Per capa-000713 was open on 09/oct/2020 it was identified the following root causes: 1.Equipment failure: the bag sealer machine id# bfm-2-1-001 was causing the weak seal condition on the joint of the tube with the bag, the generator of the equipment was identified.2.Procedure not followed: the two forms related to the procedures pm-1011 and pm-1026, for to register units with leak were not filling up, even that was identified the equipment malfunction, as well the method to test the units in both process was not followed as is required, forcing the equipment to release parts with potential leak condition.The following corrective action were implemented thru capa-000713, the current status of the capa is in voe (verification of effectiveness) 1.The rf generator of the bag sealer machine id# bfm-2-1-001 was replaced on september 10, 2020.2.Update procedure pm-1011 ?cassette leak testing, install ffp clip and luer capping? to adequate better flow in the execution of the manufacturing activities was implemented on may 24, 2021.
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