INFUSOR

Additional Manufacturer Narrative

E1: INITIAL REPORTER ADDRESS: (B)(6). E1: INITIAL REPORTER POSTAL CODE: 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 CONTAINED 4850MG OF FLUOROURACIL IN SODIUM CHLORIDE 0.9% WITH A TOTAL VOLUME OF 230ML. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.