A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.The returned sample was visually inspected, and pump elastomer was slightly lifted.A pressure leak test was then conducted on the cassette utilizing an external pressure source and fluid leakage was observed between the infusion chamber and pinch plate of the cassette.The source of the customer's complaint is due to a leak between the infusion chamber and pinch plate.This issue is consistent with an inadequate weld between the two components which will cause the cassette to fail during console setup and result in the customer's experience.The root cause of the leak is related to a weld error between the infusion chamber and cassette pinch plate.While the elastomer was lifted in returned condition, manufacturing 100% leak and flows each cassette after assembly and this issue would have been detected and rejected.It's possible the elastomer was lifted post-receipt of the sample.No action will be taken for this occurrence.Based on our current tracking, there are no adverse trends for this reported complaint and lot.In-process controls are established to ensure each final assembled cassette is verified that all required tests have been performed and all acceptance criteria are met to mitigate reoccurrence of this complaint issue.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
|