Exemption number e2015012.B.Braun medical inc (importer) is submitting this report on behalf of b.Braun avitum ag (manufacturer).This report has been identified as b.Braun avitum internal report # (b)(4).The component was not provided for evaluation as well as further information about the inspection of the dialog+ machine.The analysis of the data record of the dialog+ machine showed that the machine restarted 02:31 [hh:mm] into therapy after a power failure.The cause of this power failure is unknown.The alarm "system restored after power failure" (alarm code 600) was triggered indicating this situation.After the restoration of the system after the power failure, the blood pump did not start again.This was indicated by the alarm "blood pump is stationary (sup)" (alarm code 1957) about 2 minutes after the power came back.Thereafter, the therapy was terminated although 15 min of the scheduled time was still left.According to the customer, this became necessary because the blood in the extracorporeal circuit had clotted.The described failure of the screen cannot be determined from the trend data analysis.Even if the display fails, the therapy continues.The controller and the supervisor operate independently from the display.Thus, the control and surveillance functions remain active.In case the monitor fails to operate, it is recommended to terminate the therapy.This is always possible by using the hardware-keys of the machine.The respective procedure is described in the instructions for use of the dialog+ machine chapter 13 "operation in case of monitor failure".In contrast to the customer's description, the respective alarms were triggered according to the trend analysis.Even if the loudspeaker would have been inoperative, the speaker of the motherboard would have sounded.In addition, the alarm would have been indicated by the status lights of the machine.Since the loudspeaker is tested during the self-test in the preparation phase, an inoperative loudspeaker would be detected and alarmed during the following preparation phase of the dialysis machine.Based on the investigation the cause of the failure described by the customer cannot be determined.Therefore, no further actions will be taken.The potential blood loss resulting from the exchange of the extracorporeal circuit because of clotting would not compromise a patient.If additional pertinent information becomes available a follow-up report will be filed.
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