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. THE DEVICE WAS FILLED WITH 76 ML OF FLUOROURACIL AND 164 ML OF SALINE. THE EXPECTED INFUSION TIME WAS 46 HOURS; HOWEVER, THE DEVICE REMAINED FULL. APPROXIMATELY 10 ML WAS INFUSED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.