A surgeon reported to a company representative that he experienced poor infusion requiring him to increase the pressure, along with aspiration that was lower than expected, during two procedures.The procedures were completed with the same cassette paks.There was no harm to the patients.This is one for three reports for this surgeon.
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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.No sample has been returned for evaluation; therefore, the condition of the product could not be verified.The root cause of the customer's complaint could not be conclusively determined as a sample was not received and the condition of the product could not be verified.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.All lots are verified that all required tests have been performed and all acceptance criteria are met prior to release.The manufacturer internal reference number is: (b)(4).
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