The customer reported they had released tpn bags for patient use after bypassing occlusion errors, which occurred during tpn production on port # 24 of an exactamix® compounder.Bypassing occlusion errors can lead to an under delivery of ingredients.The tpn bags were administered to patients; however, no patient injury, adverse event, or medical intervention was reported by the customer in relation to this event.
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(b)(4).Date of event is unknown.Evaluation summary: the device was returned for evaluation and was visually inspected and functionally tested.Functional testing could not duplicate the reported occlusion errors; however, port # 24 on the compounder failed to consistently open during the testing due to evidence of spilled ingredients.A service history review was performed, finding no relationship between the reported event and previous servicing of the device.Based on the customer report of releasing tpn bags after bypassing occlusion alarms during tpn production, the cause of the reported event was determined to be user error.The exactamix operator manual instructs the user to discard the bag when occlusion alarms occur during production.
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