MEDEX

Additional Manufacturer Narrative

OTHER TEXT: ONE UNIT WAS RETURNED FOR EVALUATION. THE UNIT WAS TESTED AND LEAKAGE WAS FOUND FROM THE FILTER COMPONENT SUPPLIED FOR USE DURING MANUFACTURE OF THE SET. THE DEVICE WAS FORWARDED TO OUR SUPPLIER FOR FURTHER TESTING. THE SUPPLIER CONFIRMED THE LEAK AS WELL, AND NOTED THAT THE EVENT WAS LIKELY CREATED DUE TO CRACKS WHICH COULD NOT BE CONTRIBUTED TO THE MANUFACTURING PROCESS. THE CRACKS FOUND ARE OFTEN ASSOCIATED WITH OVERTIGHTENING OR ALCOHOL USE. A DEVICE HISTORY REVIEW WAS CONDUCTED AND FOUND NO DISCREPANCIES.

Description of Event or Problem

INFORMATION RECEIVED A SMITHS MEDICAL INFUSION EXTENSION SETS AND DISPOSABLES/MEDEX EXTENSION SETS SINGLE LINE HAD LEAKING OF MEDICATION. REPORTED BY PATIENTS FATHER AT 0955 , HE CALLED THIS RN TO BEDSIDE TO NOTIFY HER THAT PATIENT IS LEAKING FROM SMOFLIPID LINE. UPON ASSESSMENT, IT APPEARED THAT LIPIDS WERE BACKFLOWING INTO LINE, THEREFORE CAUSING PRESSURE TO BUILD. RN ASSISTED THIS RN IN CHANGING OUT THE FILTER. SMOFLIPIDS WERE INFUSING WELL AFTER CHANGE.