BLOOD RECIPIENT SET

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H4, H6 (UPDATE CODES), H11. CORRECTION: D4 EXPIRATION DATE (UPDATE TO N/A), UDI #. H11: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. 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 A Y-TYPE BLOOD/SOLUTION SET WITH STANDARD BLOOD FILTER BACKFLOWED DURING PLATELET TRANSFUSION. (B)(4) UNIT (291 ML) OF PLATELETS WAS INTENDED TO INFUSE OVER ONE HOUR. THE STAFF PRIMED BLOOD TUBING WITH SODIUM CHLORIDE 0.9% 500ML BAG AND CLAMPED TUBING CONNECTED TO THE NORMAL SALINE BAG. SPIKED THE PLATELET BAG AND BEGAN TRANSFUSION. NEAR THE END OF THE TRANSFUSION, STAFF NOTED THAT THE PLATELET BAG VOLUME HAD NOT DECREASED AS EXPECTED AND DISCOVERED THAT THE ENTIRE 500 ML SALINE BAG HAD BACKFLOWED INTO THE PLATELET BAG DESPITE THE CLAMP BEING FULLY CLOSED. THE DILUTED PLATELETS WERE TRANSFUSED WITHIN A 4 HOUR TIME FRAME. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.