CLEARLINK BLOOD RECIPIENT SET

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS ADDED TO D9, H3, H4, H6, AND H10: H10: THE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED, AND IT WAS NOTED THAT THE SPIKE WAS SEPARATED FROM THE TUBING. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE REPORTED CONDITION WAS A MANUFACTURING ISSUE. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT A CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET LEAKED. THE TUBING CONNECTED TO THE SPIKE END ATTACHED TO A PLATELET UNIT DETACHED. THIS WAS OBSERVED DURING SETUP, AFTER THE TUBING WAS SPIKED WITH SALINE AND PLATELETS (THE UNITS WERE INVERTED). THE NURSE WAS SPLASHED BY THE PLATELET UNIT; HOWEVER, THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

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