MEDEX IV FILTER EXTENSION SET

Additional Manufacturer Narrative

NO PRODUCT WAS RECEIVED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.

Description of Event or Problem

IT WAS REPORTED THAT THE DEVICE'S FILTER WAS LEAKING WHILE IT WAS USED ON THE PATIENT FOR AN INFUSION. THE LEAKING CAME FROM THE SEAL BETWEEN THE FILTER AND THE LINE PROXIMAL TO THE PATIENT. NURSING BROUGHT SYRINGE AND LINE BACK TO CHANGE LINES OUT, HOWEVER TECH COULD NOT DRAW FLUID BACK FROM THE IN-LINE FILTER AT ALL. AFTER CONFIRMING WITH TEAM THAT A REDUCED VOLUME (ABOUT 1 ML PER LINE) WAS READY TO SALVAGE THERAPY TODAY, A TECHNICIAN ATTACHED A NEW IN-LINE FILTER AND PRIMED AS PER STANDARD COMPOUNDING PROCEDURE FOR BRINEURA. SAME LEAKING HAPPENED IMMEDIATELY AFTER STARTING INFUSION AGAIN. THEY DISCUSSED POTENTIALLY TO SWITCH THIS NEW LINE LOT INSTEAD WHICH WOULD RESULT IN A TOTAL OF 2.5 ML TOTAL LOSS. THE TEAM AGREED WITH REDUCED DOSE TODAY IN LIEU OF DELAYING THERAPY FOR DAYS OR ANOTHER WEEK. THEY CONFIRMED THAT THERE WAS NO ISSUE WITH LEAKING WITH THIS NEW LINE. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE OUTCOME OF THE EVENT WAS RESOLVED AND NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

H2) DEVICE EVALUATION: H3, H6: NO PRODUCT WAS RETURNED. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. IF THE PRODUCT IS RETURNED THIS COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURING.