MRIDIUM MRI SYRINGE ADAPTER SET 1000 SERIES

Description of Event or Problem

WHEN USING THE IRADIMED 1057 VENTED SYRINGE SET LOT 22L02N WITH THE IRADIMED SYRINGE PUMP WE HAD TWO FAULTS OCCUR DUE TO OCCLUDED VENT TUBES. THIS PRODUCT IS USED IN OUR MRI ROOMS. THE OCCLUSIONS ARE THERE FROM THE MANUFACTURER. THE FIRST FAULT THAT WE EXPERIENCE CAUSED THE PUMP TO ALARM FOR INLET OCCLUSION. THIS STOPPED THE INFUSION RESULTING IN A DELAY OF PATIENT CARE. NURSING STAFF HAD TO STOP THE SCAN AND REPLACE THE PATIENT'S IV SET. THE SECOND FAULT CAUSED PROPOFOL TO LEAK FROM THE TUBING DIRECTLY ABOVE THE FLOW PREVENTER. THE TUBING WAS REPLACED. UPON A SAMPLE INSPECTION OF OTHER NEW SETS IN STOCK WE FOUND TWO MORE THAT HAD OCCLUDED VENTS. THIS LOT HAS BEEN REPLACED. THE DEFECTIVE SETS WERE RETURNED TO IRADIMED FOR EVALUATION.