(b)(4).Failure analysis and investigation results did not confirm the reported issue.Upon receipt the actual pump involved was visually and functionally inspected.Three (3) volumetrics of 100 ml/hr were performed with a 30ml bd syringe, and all of the test results were within specification.The pump operated as intended and the reported failure could not be reproduced.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number.Based on the results of the investigation, no conclusions can be made regarding the cause of the reported event.It should be noted that a log review indicated that both a 30ml bd syringe and a 50ml bd had been confirmed for infusions.The instructions for use state that, "syringe must be mounted with flange upright into the slot," and a warning label is placed on the inside of the syringe holder giving indication of this.In addition, the ifu states that,"prior to starting an infusion, verify that the syringe size and model on the syringe pump's display screen match the syringe size and model that were loaded into the pump." if the correct syringe is not confirmed it can result in a false volume delivered.If additional information becomes available, a follow up report will be submitted.
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