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.Based on current tracking, there are no adverse trends for this reported complaint.No sample was returned for evaluation, but a photo was provided by the customer.The photo confirmed that the infusion chamber on the cassette was cracked, however the root cause of the damage could not be determined from the image.While the photo confirmed that the infusion chamber on the cassette was cracked, the root cause of the customer's complaint could not be conclusively determined as a sample was not returned for evaluation.Without analysis of the sample, it is not possible to isolate the root cause.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.The root cause for this complaint is not known, therefore, specific action with regards to this complaint cannot be taken.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 prior to release.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).
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