INFUSOR

Additional Manufacturer Narrative

E1: INITIAL REPORTER ADDRESS: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT A LARGE VOLUME INFUSOR UNDERINFUSED DURING PATIENT INFUSION VIA A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC). THE DEVICE WAS FILLED WITH 5 FLUOROURACIL (5 FU). THE MEDICATION WAS EXPECTED TO INFUSE OVER 46 HOURS; HOWEVER, THE INFUSION WAS APPROXIMATELY 85% COMPLETE AFTER APPROXIMATELY 71 HOURS OF INFUSION TIME. THE RATE WAS REPORTED TO BE SLOWER THAN NORMAL. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.