(b)(4).The device was not returned for evaluation as there was no indication of device failure.However, the customer did provide baxter with the mixcheck report (the mix check report reports information regarding the completed bag including the expected bag weight, measured bag weight, ordered ingredients and volumes, manual additions that are required for the specific order, and any error encountered during the pumping of the bag) and the device's event log, both of which confirmed the device appropriately alerted the user, with occlusion alarms, to possible flow issues.Additionally, the mixcheck report confirmed the bag was approved for release despite the occlusion alarms being present on the report.Baxter technical support informed the customer of the manufacturer recommendation to discard bags that receive occlusion alarms during production.
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While troubleshooting a report of a possible under delivery of nacl in a tpn bag produced with an exactamix em2400 compounder, baxter technical support discovered that the user had received occlusion alarms during the production of the tpn bag but did not discard the bag per manufacturer recommendations.Instead, the tpn bag was released and administered to a patient.Occlusion alarms can indicate improper solution flow during compounding, which can result in under-delivery of ingredients.There was no patient injury, adverse event, or medical intervention necessary in relation to this event.No additional information is available.
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