(b)(4).One used space pump set, with packaging identifying the reported lot number 0061316407, was received for evaluation.The set was spiked into a baxter pab bag of magnesium sulfate in 0.9% sodium chloride solution.The returned set was loaded into an infusomat space pump and primed on the pump with the remaining solution from the returned pab bag.The pump rate was set at 325 ml/hr.All remaining fluid from the pab bag then ran through the set without any alarms or air bubbles observed.Next, the set was manually primed with a normal saline solution and loaded into an infusomat space pump as per the instructions for use.The pump was set at the same rate and allowed to run for 20 minutes.During this time, there were no air bubbles observed in any location of the tubing set and the pump did not alarm any errors.Furthermore, the set was subjected to occlusion and air pressure (leakage) tests according to specification with acceptable results.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number.There were no other reports of this nature against the reported lot number.Based on the results of this investigation, no conclusions can be made regarding the cause of the reported event.The returned sample met requirements according to specification.If additional pertinent information becomes available, a follow-up report will be filed.
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