CLEARLINK

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.

Additional Manufacturer Narrative

G1: DEVICE MANUFACTURER ADDRESS 1: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET WAS LEAKING THROUGH THE TOP OF THE PUMP. THE LEAK WAS DISCOVERED DURING USE OF THE DEVICE WITH BLOOD. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.