CLEARLINK

Additional Manufacturer Narrative

E1: INITIAL REPORTER POSTAL CODE:(B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT AN UNDER INFUSION OF MEDICATION OCCURRED DURING THE USE OF A VENTED PACILITAXEL SET WITH CLEARLINK. AN OVERNIGHT INFUSION OF AMIODARONE WAS PREPARED, AND THE NEXT DAY IT WAS OBSERVED THAT AN UNDERINFUSION HAD OCCURRED. THIS WAS OBSERVED AFTER THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

H11: THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.