(b)(4).Based on the review of the software logs at exactly 1:31:10 pm the compounder attempted to perform several manifold flushes into a waste container but there was no volume or weight being added to the scale with each flush sequence.This indicates that the output line to the waste container was clamped off or restricted causing back pressure into the system.At approximately 1:33 pm a new bag is placed on the scale and a successful manifold flush occurs.As per the engineer, the investigation included a review of each prime dispense request and looked at the scale readings.It was discovered that the first prime request did not increase the scale weight in relation to the amount of fluid requested.This aligns with the report of the discovery of fluid in the empty line.The transfer set and bags were changed and the user was able to continue normally.We recommend, prior to attempting to flush into a waste container, that the user ensures the outlet tubing is not pinched or obstructed and that the bag clamp is in the open position.Based on the results of the investigation, the pump operated as intended.If additional pertinent information becomes available a follow-up report will be filed.Manufacturer report numbers 1641965-2017-00047, and 1641965-2017-00048 were all reported from the same user facility.
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