ANGIOMAT ILLUMENA

Description of Event or Problem

CUSTOMER STATES THAT THE INJECTOR WAS ARMED READY TO SHOOT THE DYE WHILE OVERDRIVE PACING, BUT THEY PUSHED THE BUTTON FOR THE INJECTOR AND NOTHING HAPPENED. THE CUSTOMER TRIED AGAIN AND NOTHING HAPPENED, AND AS A CONSEQUENCE, THE OVERDRIVE PACING LASTED LONGER THAN INTENDED. CUSTOMER THINKS IT MIGHT BE ERROR CODE 1072 OR 1079, NOT ENTIRELY SURE. PATIENT WAS BEING PACED AT A HIGH RATE WAITING FOR INJECTION TO TAKE PLACE. AT THIS POINT THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION, WHICH LED TO THE PATIENT EXPERIENCING CARDIAC ARREST, CODE WAS CALLED, PATIENT WAS PUT ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO), TAKEN UP TO ICU STILL ON ECMO. SINCE FOLLOWING UP YESTERDAY MORNING, THE PATIENT HAS NOT IMPROVED AND REMAINS THE SAME. UPDATE ON 24JUL18: INJECTOR SHOWED AN ALARM 1072 AFTER THE SYSTEM WAS ARMED AND THEY ATTEMPTED TO INJECT DURING TRANS CATHETER AORTIC VALVE REPLACEMENT AT THE TIME THE BALLOON PLASTY WAS OCCURRING. ATTEMPTED TO INJECT AND THE INJECTOR THEN DISPLAYED THE ERROR CON 1072. THIS INDICATES A SOFTWARE CORRUPTION ON THE CONSOLE. WE WILL NEED TO FURTHER INSPECT, CUSTOMER IS NOT CURRENTLY WITH THE INJECTOR, FSE WILL NEED TO ADDRESS THE KNOWN ISSUE. UPDATE ON 26JUL18: PATIENT WAS FINE BEFORE THE PROCEDURE, WALKING AND TALKING, AND EVEN VOTING ON TUESDAY DURING THE (B)(6) ELECTION, AND NEEDED A VALVE REPLACEMENT WITH MINIMALLY INVASIVE SURGERY. STS (SHORT TERM RISK SCORE) DONE FOR THE PATIENT TO ASSESS RISK FOR MORTALITY DEMONSTRATED A LOW MORTALITY RISK FOR THIS PATIENT AND COULDN'T REMEMBER THE EXACT SCORE, BUT REPORTER STATES THAT IT DOES NOT LOOK VERY PROMISING FOR THE PATIENT. UPDATE ON 02AUG18: REACHED OUT TO REPORTER FOR A FOLLOW-UP ON PATIENT WHO EXPERIENCED CARDIAC ARREST FOLLOWING THE INJECTOR MALFUNCTION. PATIENT SEEMS TO BE DOING BETTER AND HAS BEEN WEANED OF ECMO, CURRENTLY HAS PNEUMONIA AND EXTUBATING, PATIENT IS AWAKE AND STAFF IS ASSESSING HIS NEUROLOGICAL CONDITION. REPORTED COULD NOT SPEAK ON NEUROLOGICAL CONDITION AT TIME OF PHONE CALL. UPDATE ON 10AUG18: REACHED OUT TO REPORTER TO OBTAIN ANOTHER FOLLOW-UP REGARDING THE PATIENT, AND SHE STATED THAT THE PATIENT RECOVERED COMPLETELY AND WAS DISCHARGED ON (B)(6) 2018.