The system was used for treatment.Since the device could not be ruled out as a possible contributing factor to this event, this case will be reported as a mdr out of an abundance of caution.Since this event is associated with the treatment, this mdr will be against the instrument.From the device perspective, there was no known device malfunction and no instrument issue was alleged by the customer.The instrument's serial number was not provided; therefore, the device history review could not be conducted.Trends were reviewed for complaint categories, infection and sepsis.No trends were detected for these complaint categories.The assessment is based on information available at the time of the investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.Adverse event terms: infection and sepsis.(b)(4).
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