Additional Manufacturer Narrative · 1
EVAL: SAMPLES FROM THE SAME LOT WERE FUNCTION AND DIMENSION TESTED AND NO PROBLEMS WERE NOTED. A SMITHS MEDICAL DEVELOPMENT ENGINEER WENT TO THE USER FACILITY TO PERFORM AN INVESTIGATION INTO THE ACTUAL SAMPLE. A VISUAL INSPECTION OF THE TUBING SET WAS NOT ABLE TO CONFIRM THE ROOT CAUSE. IT DID IDENTIFY ABNORMALITIES AT THE REFLUX CONNECTOR (PROXIMAL END), HOWEVER, THERE WAS NOT ANY CONCLUSIVE EVIDENCE THAT THIS WAS THE POINT OF FAILURE. A FUNCTIONAL TEST WAS PERFORMED AND THE RECIRCULATING FLUID LEAKED OUT THE DISTAL END IMMEDIATELY. THE LOCATION OF THE BREACH WAS ISOLATED TO BE IN THE REFLUX CONNECTOR END OF THE TUBING SET, BUT WE WERE UNABLE TO DETERMINE THE EXACT LOCATION OF THE FAILURE. WE ASKED IF WE COULD TAKE THE TUBING SET FOR FURTHER ANALYSIS AND WERE TOLD "NO" AND ALSO TOLD THAT WE COULD NOT CUT THE TUBING TO DETERMINE THE EXACT FAILURE. WE ARE STILL TRYING TO GET AUTHORIZATION TO HAVE THE SAMPLE RETURNED FOR FURTHER INVESTIGATION. WE HAVE NOT RECEIVED ANY OTHER REPORTS ON THIS DEVICE LOT NUMBER AND A REVIEW OF THE MFG RECORDS DID NOT REVEAL ANY DETAILS THAT WOULD IMPACT REPORT. WE WILL SUBMIT A FOLLOW UP REPORT TO INFORM YOU IF WE WERE ABLE TO OBTAIN THE EVENT SAMPLE.