INFUSOR

Additional Manufacturer Narrative

SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT A CE INFUSOR OVERINFUSED. THE EVENT OCCURRED IN THE ONCOLOGY DEPARTMENT. FOLLOWING COMPLETION OF INTRAVENOUS CHEMOTHERAPY WITHOUT REPORTED COMPLICATIONS, AN ELASTOMERIC INFUSION PUMP WAS CONNECTED FOR A PLANNED 46 HOUR ADMINISTRATION. THE PATIENT RETURNED TO THE MEDICAL UNIT TWO DAYS LATER FOR PUMP REMOVAL, AT WHICH TIME AN ACCELERATED INFUSION WAS IDENTIFIED. THE PUMP CONTENTS HAD BEEN COMPLETELY INFUSED IN APPROXIMATELY 42 HOURS AND 32 MINUTES, EARLIER THAN THE INTENDED DELIVERY TIME. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THESE EVENTS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.