CLEARLINK BLOOD RECIPIENT SET

Description of Event or Problem

IT WAS REPORTED THAT A CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET LEAKED. TUBING UNDER FILL CHAMBER WAS DISCONNECTED FROM CHAMBER THAT LED TO LEAKAGE. THIS EVENT OCCURRED DURING PATIENT INFUSION. THE DEVICE CONTAINED PLASMA. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

THE USER FACILITY SUBMITTED MEDWATCH (B)(4) FOR THIS EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS ADDED TO H6 AND H10: H10: 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.