MRIDIUM SERIES 1000 INFUSION SETS

Additional Manufacturer Narrative

THIS COMPLAINT CAME FROM A CUSTOMER REPORT OF AN OBSERVATION OF INLET OCCLUSIONS IN THEIR RESPONSE TO THE PRODUCT CORRECTION NOTIFICATION. NO PATIENT INJURY WAS REPORTED AS PART OF THE USE OF THE DEFECTIVE DEVICE. SINCE THIS CUSTOMER HAD NOT PREVIOUSLY MADE IRADIMED AWARE OF ANY ISSUES PRIOR TO THE RECALL BEING STARTED, THE CUSTOMER RECALL RESPONSE IS BEING CONSIDERED A NEW COMPLAINT. TO BE CONSISTENT WITH THE ORIGINAL COMPLAINTS THAT RESULTED IN THE RECALL THIS CUSTOMER COMPLAINT IS RESULTING IN A MDR IS BEING REPORTED BECAUSE THE HHE ASSOCIATED WITH THE ORIGINAL COMPLAINTS DETERMINED THAT UNDER CERTAIN SEQUENCE OF EVENTS, THE HAZARDOUS SITUATIONS (UNDERDOSE AND/OR DELAY OF THERAPY) COULD LEAD TO POSSIBLE HARMS, INCLUDING SERIOUS ADVERSE HEALTH CONSEQUENCES. THE HHE DETERMINED THAT THE SEQUENCE OF EVENTS THAT COULD LEAD TO THE HAZARDOUS SITUATION HAS A REMOTE PROBABILITY OF OCCURRING, BUT DUE TO THE LEVEL OF SEVERITY IF IT WERE TO OCCUR, IT IS BEING CONSIDERED A REPORTABLE EVENT.

Description of Event or Problem

CUSTOMER INDICATED IN THEIR RESPONSE TO RECALL Z-1310-2023 THAT THEY HAD OBSERVED THE PROBLEM DESCRIBED IN THE RECALL. NO PATIENT INJURY WAS REPORTED, BUT THIS RESPONSE IS BEING TREATED AS A NEW PRODUCT DEFECT REPORT SINCE IRADIMED WAS NOT AWARE OF THIS CUSTOMER'S ISSUE PRIOR TO THEIR RECALL RESPONSE.