CLEARLINK BLOOD RECIPIENT SET

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS ADDED TO H6. H11: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF THE SAMPLE WAS PROVIDED FOR EVALUATION. THE RETURNED PHOTOGRAPH WAS REVIEWED, AND IT WAS NOTED THAT THERE WAS A LEAK AT THE LEVEL OF THE HEAT SEAL CHAMBER. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE REPORTED CONDITION COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED THAT AN UNSPECIFIED QUALITY OF BLOOD/SOLUTION ANESTHESIA/PCA INFUSION SETS WERE CRACKED WHICH RESULTED IN A FLUID LEAK. THE LEAKS WERE OBSERVED FROM THE DRIP CHAMBER, AND THE ISSUE WAS DESCRIBED AS ¿CRACK/BREAK IN RIDGED SET COMPONENTS¿. IT WAS UNKNOWN IF A PATIENT WAS CONNECTED AT THE TIME OF THESE EVENTS. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.