BLOOD RECIPIENT SET

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS ADDED TO H6 AND H11: H11: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF THE SAMPLE WAS PROVIDED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED, AND BACKFLOW INTO THE SALINE BAG WAS OBSERVED. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

E1: INITIAL REPORTER PHONE NO.: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT A BLOOD WAS BACKING UP INTO THE Y-TYPE BLOOD/SOLUTION SET AND IT WAS OBSERVED THAT THERE WAS AIR MID FILTER. BLOOD WAS BACKING UP INTO THE SALINE BAG AND THERE WAS A POCKET OF BLOOD WITH THE FILTER. THIS OCCURRED AFTER THE INFUSION HAD STARTED. IT WAS ALSO OBSERVED THAT THERE WAS AIR MID FILTER WHILE PRIMING. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION WAS AVAILABLE.