BLOOD RECIPIENT SET

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AIR IN THE LINE OF A Y-TYPE BLOOD/SOLUTION SET. UPON SPIKING THE BLOOD CONTAINER, IT WAS OBSERVED THAT THE CHAMBER CONTAINING THE FILTER QUICKLY FILLED WITH BLOOD. TROUBLESHOOTING WAS ATTEMPTED USING VARIOUS METHODS, BUT IT WAS OBSERVED THAT THERE WERE BUBBLES FORMING IN THE LINE ABOVE THE PUMP, AT WHICH POINT THE INFUSION WAS STOPPED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D10, E1: INITIAL REPORTER PHONE NO., H4, H6, H11. H11: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, PHOTOGRAPHS OF THE SAMPLE WERE PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE PHOTOGRAPHS SHOWED AIR DROPS (BUBBLES) INSIDE OF THE TUBING. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.