Other, other text: h6: event problem and evaluation codes: updated after device evaluation h10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Sample received: two (2) samples were received from p/n 21-7052-24 l/n 4152708; the samples was returned decontaminated inside a plastic bag without its original package.Visual inspection result: no discrepancies or damage was observed in the returned samples.Functional testing: in order to reproduce the failure mode reported for the customer a cassette product was taken from production floor and filled as cassette ifu indicate, extension set were connected to the luer to perform a functional using a pump cadd legacy plus [cal.Id: 1.0386; due date: february 2022]; the pump was started and the alarm was activated, so the reported failure mode is confirmed.Functional test: sample was tested using a syringe with colored water to detect any occlusion.Results: during the test, the water did not pass-through filter.Complaint was confirmed.The cause of the reported problem was traced to the manufacturing process, root cause is excess of solvent by not following the manufacturing procedure.Personnel notification was performed on (b)(6) 2022 to notify production personnel about the failure mode reported by the customer.
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