FOLFUSOR

Description of Event or Problem

IT WAS REPORTED THAT TWO (02) SMALL VOLUME FOLFUSORS UNDERINFUSED DURING PATIENT INFUSION. THE ADMINISTRATION DURATION WAS 48 HOURS; HOWEVER, AT THE 48 HOUR MARK, THE ENTIRE CONTENTS OF THE DIFFUSER HAD NOT BEEN FULLY ADMINISTERED. ADMINISTRATION WAS THEREFORE EXTENDED TO 72 HOURS, FOLLOWED BY THE REMOVAL OF THE DIFFUSERS. THE DEVICES WERE FILLED WITH A TOTAL VOLUME OF 97 ML CONTAINING FLUOROURACIL AND 5% GLUCOSE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

(B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.