(b)(4).One used space pump iv tubing set, without packaging, was received for evaluation.The proximal ultrasite valve was connected to a phaseal adapter, which was piggybacked into a secondary iv set.The pump set was received spiked into a hospira 250ml pab bag of 0.9% sodium chloride, with approximately 200ml of solution remaining in the bag.The secondary set was spiked into an empty b.Braun pab bag.The sets were visually examined and there was a section (approximately 18 inches) of air observed directly below the pump segment in the primary set, and other air bubbles of varying size observed throughout the secondary set.In an attempt to replicate the reported event, the returned sets were primed with normal saline, and loaded into an infusomat space pump as per the instructions for use.There were no air bubbles observed within the tubing lines while the set was running in the pump, and the pump did not alarm any errors.Furthermore, the sets were subjected to air pressure (leakage) testing according to specification with acceptable results.Based on the results of this investigation, no specific conclusions can be made regarding the cause of the reported event.The returned sample met requirements according to specification, and the reported failure could not be reproduced.Given the returned set was received with air below the pump segment and no fluid remaining in the secondary bag, a potential cause appears to be that the secondary bag ran empty resulting in the air in the tubing and pump alarm.If the primary line is clamped off, then air will draw into the line from the empty secondary bag.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number.Without the lot number, a thorough batch record review could not be performed.If additional pertinent information becomes available, a follow-up report will be filed.
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