INFUSOR

Additional Manufacturer Narrative

E1: INITIAL REPORTER FACILITY NAME: (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 COMPLETED INFUSION AROUND 10 HOURS EARLIER THAN EXPECTED. THE ISSUE OCCURRED DURING PATIENT INFUSION. THE DEVICE WAS FILLED WITH FLUOROURACIL (3.5G OF ACTIVE INGREDIENT) AND THE DILUENT 0.9% NORMAL SALINE (80ML) HAVING THE FILL VOLUME OF 220ML. THE EXPECTED INFUSION TIME WAS 44 HOURS. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.