SMITHS MEDICAL MEDEX INFUSION EXTENSION SETS AND DISPOSABLES

Additional Manufacturer Narrative

ONE INFUSION EXTENSION SET WAS RETURNED FOR EVALUATION. SAMPLE UNDERWENT FUNCTIONAL TESTING TO DETECT FOR LEAKAGE. NO LEAKAGE WAS OBSERVED, THEREFORE CUSTOMER REPORTED COMPLAINT WAS NOT CONFIRMED. WHILE NO DEFINITIVE PROBLEM SOURCE TO THE REPORTED ISSUE COULD BE DETERMINED, THIS INVESTIGATION REVEALED NO INTRINSIC EVIDENCE TO SUGGEST A CAUSE OF ISSUE RELATED TO MANUFACTURING.

Description of Event or Problem

INFORMATION WAS RECEIVED THAT WHILE A SMITHS MEDICAL INFUSION EXTENSION SET WAS IN USE IN THE NICU, IT WAS NOTED TO BE LEAKING AT THE CONNECTION. IT WAS NOTED TO BE ABOUT 8 CM X 10 CM AREA. A PIV WAS PLACED, AS WELL AS LABS DRAWN FOR COMPLETE BLOOD COUNT. HEMATOCRIT WAS REPORTED TO HAVE DROPPED FROM 42 TO 30, AND RED BLOOD CELLS WERE ORDERED TO BE TRANSFUSED. THE PHARMACY WAS NOTIFIED TO SEND STAT TOTAL PARENTAL NUTRITION FOR PIV.