CLEARLINK

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SETS HAD CONSTANT ALARMS FOR THE PRESENCE OF AIR BUBBLES, WHILE THERE ARE NO AIR BUBBLES. THE ISSUES WERE IDENTIFIED DURING PATIENT INFUSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H4, H6 (UPDATE CODES), H11. H11: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.