The lot complaint history and a device history record (dhr) were not reviewed as no lot information was available for this complaint.The fluidics management system (fms) are single-use medical devices provided to the customer in a sterile manner.An evaluation is conducted to ensure each fms meets customer, process, and regulatory requirements.Once the fms is assembled and sealed, they are all sterilized as a complete unit.The sterilization validation has taken into account the worst case of the procedure pak to ensure all fms meet sterilization cycle parameters for acceptability prior to release.A sample was not returned; therefore, the root cause for the customer reported event cannot be determined.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.The fms are single-use items provided to the customer in a sterile manner.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).
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