CLEARLINK

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AIR IN THE LINE OF A CLEARLINK Y-TYPE BLOOD/SOLUTION SET WITH STANDARD BLOOD FILTER. THIS ISSUE WAS OBSERVED WHILE HANGING BLOOD FOR A PATIENT. TO RESOLVE THIS ISSUE, AN NEW SET WAS USED AND THE BLOOD WAS ABLE TO BE INFUSED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS ADDED TO A2, A3A, A4, A5, A6, D5, E4, H4, H6, H10, AND 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.