BLOOD RECIPIENT SET

Description of Event or Problem

IT WAS REPORTED THAT A BLOOD WAS BACKING UP INTO THE Y-TYPE BLOOD/SOLUTION SET WITH A STANDARD BLOOD FILTER 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.

Additional Manufacturer Narrative

D4: LOT # - THE SUSPECT LOT NUMBER WAS BR24I06086. E1: INITIAL REPORTER PHONE NO. - (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS ADDED TO H6. H11: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, PHOTOGRAPHS OF THE SAMPLE WERE PROVIDED FOR EVALUATION. THE PHOTOGRAPHS WERE REVIEWED, AND IT WAS NOTED THAT THERE WAS BACKFLOW INTO THE SALINE BAG. 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.