SERIES 1000 INFUSION SETS

Description of Event or Problem

WHILE SETTING THE MRI PUMPS THE MEDICATION IV DRIP WAS DISCONNECTED FROM THE PUMP AND HOOKED TO THE MRI TUBING FOR PRIMING. THE TUBING WAS PRIMED WITH A PARTIAL BAG AND A NEW BAG, THE PRIMARY TUBING FOR THE PUMP WAS ALSO CHANGED AT THIS TIME. ONCE THE NEW PRIMARY TUBING, MRI TUBING, AND ONE SET OF EXTENSION TUBING WAS PRIMED, THE TUBING WAS CONNECTED TO THE MRI PUMP CHANNEL 4A AND SET THE RATE WHICH THE PATIENT HAD BEEN ON. CONTINUOUS BUBBLE ALARMS AND A COUPLE PATIENT OCCLUSION ALARMS PROCEEDED. THIS CONTINUED WHILE SETTING UP THREE OTHER MRI PUMPS. WHILE ATTEMPTING TO TROUBLESHOOT THE MRI PUMP, THE IV DRIP KEPT INFUSING WHEN THE ROLLER WAS SET TO CLAMPED AND SHOULD HAVE AUTOMATICALLY BEEN CLAMPED REGARDLESS VIA THE TUBING ITSELF WITHOUT THE ROLLER CLAMP. THE PATIENT DID NOT SUFFER ANY HARM DURING THE EVENT.

Additional Manufacturer Narrative

ON APRIL 13,2023, THE FDA NOTIFIED IRADIMED CORPORATION OF AN EVENT THAT OCCURRED ON (B)(6)2013. THERE WAS NO PATIENT INJURY IN THE REPORTED EVENT. THE EVENT WAS EVALUATED AND DETERMINED TO HAVE THE POTENTIAL TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WER TO RECUR AND IS THEREFORE BEING REPORTED AT THIS TIME. THE EVENT INVOLVED A 1058 INFUSION SET MANUFACTURED ON (B)(6) 2022 WITH AN EXPIRATION DATE OF 7/31/2024.