Description of Event or Problem · 1
A PATIENT IN THE CARDIAC CATHETERIZATION LAB WAS CONNECTED TO AN *INJECTOR WHEN THE SYRINGE DISINTEGRATED. THE INJECTOR HAD A PRE-FILLED SYRINGE (OPTIRAY ) ATTACHED, AND THE DEVICE OPERATOR HAD PRIMED IT. THE OPERATOR TAPPED IT TO GET RID OF THE BUBBLES IN THE SYRINGE. SYRINGE. WHEN THE OPERATOR INITIATED THE INJECTION OF THE SOLUTION, THE SYRINGE CAME APART. THE UNIT WAS REMOVED FROM THE DEPARTMENT AND SENT TO BIOMEDICAL ENGINEERING FOR FURTHER EXAMINATION. THE MANUFACTURER, MALLINCKRODT (LIEBEL-FLARSHEIM CO), WAS CONTACTED AND THEY SENT A TECHNICAL REPRESENTATIVE TO TEST THE UNIT. THEIR REPRESENTATIVE CONCLUDED THE UNIT WAS FUNCTIONING NORMALLY , SO THE ONLY SUSPECT COMPONENT REMAINING WAS THE SYRINGE. UNFORTUNATELY THE BROKEN SYRINGE WAS DISPOSED OF AT THE TIME OF THE INCIDENT. THE INJECTOR WAS RETURNED TO SERVICE. THE PATIENT WAS NOT HARMED BY THIS MALFUNCTION. THE VENDOR GENERATED A SERVICE REPORT AND SENT IT TO BIOMEDICAL ENGINEERING. THE REPORT INDICATED THE MACHINE WAS WITHOUT FAULT. THE ACTING SUPERVISOR WAS REMINDED THAT THE PERSONNEL IN THE DEPARTMENT NEED TO KEEP ALL COMPONENTS INVOLVED IN DEVICE INCIDENTS.