When bag dry spike with icu medical's chemolock additive port (cl-12) was affixed to bd alaris low sorbing administration set (ref #(b)(4)), there is a potential for coring to occur, this became visible in the drop chamber of the tubing set, and may occur at any time during administration.We witnessed this on the patient towards end of 3 hour infusion.This has happened on two separate occasions with same devices but different medications.We stopped the infusion immediately and do not believe any of the floating 2mm size plastic particulates in the line were infused into the patient.Patient did not have any complaints or other adverse effects from this occurrence.Test completed to ensure aseptic infusion conditions were maintained.Fda safety report id # (b)(4).
|