It was reported during patient infusion with a clearlink continu-flo solution set, the male luer of the set disconnected from the central line of the patient which resulted in a leak.It was further reported ¿diachylon" on the end of the tubing was observed.The patient was receiving fentanyl (150 mcg/hr.), insulin ("iv" 20ml/hr.) and propofol (unreported dose) at the time of the event.Subsequently, the patient experienced agitation, hyperglycemia and was less sedated due to the event.The tubing was changed, and the medication was restarted.After the insulin was restarted the patient glucose was 21.1 and 23.3 (units not reported).The cause of the disconnection was unknown.The patient returned to ¿normal glycemia¿ and the agitation was resolved.No additional information is available.
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H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was discarded; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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