Description of Event or Problem · 0
IT WAS REPORTED THAT THE BLUE SAFETY LOCK CLAMP (LOWER FITMENT) DID NOT ENGAGE WHILE REMOVING THE TUBING FROM A NITROGLYCERIN INFUSION, WHICH CAUSED AN OVER INFUSION AND A DROP OF THE PATIENT'S BLOOD PRESSURE TO 75/41. NITROGLYCERIN 100 MG IN 250 ML WAS PROGRAMMED TO INFUSE AT 10MCG/MIN UNTIL DISCONNECTION OCCURRED AT APPROXIMATELY 1500-1600. THE CLINICIAN STATED THAT THE TUBING WAS REMOVED FROM THE CHANNEL, AND UPON REMOVAL, THE BLUE CLAMP DID NOT SLIDE FORWARD TO COMPLETELY CLOSE THE TUBING. THIS RESULTED IN A RAPID INFUSION OF NITROGLYCERIN, CAUSING A DROP IN THE PATIENT'S BLOOD PRESSURE TO 75/41 AT 2050. THE NURSE STATED SHE ASSUMED THE BLUE CHANNEL SAFETY LOCK WOULD CLAMP THE TUBING WHEN SHE REMOVED IT FROM THE PUMP, AND THEREFORE WOULD NOT HAVE TO USE ANOTHER CLAMP. AT THE TIME, NOREPINEPHRINE AND AMIODARONE WERE INFUSING. THE PATIENT'S CHEST TUBE DRAINAGE WAS THEN NOTED TO BE INCREASING UP TO 200 ML/HR. THE CLINICAL STAFF WAS UNABLE TO QUICKLY GET BLOOD TO THE PATIENT; THE MD WAS NOTIFIED, AND A CODE HEMORRHAGE WAS CALLED. THE PATIENT WAS DIFFICULT TO AROUSE, AND NARCAN WAS GIVEN, HOWEVER, THE PATIENT WAS NOT RE-INTUBATED. ANESTHESIOLOGY ARRIVED AND NOTICED THE BOTTLE OF NITROGLYCERIN WAS EMPTY AND WAS NOT ATTACHED TO THE PUMP MODULE. THE PATIENT RESPONDED WELL TO A BLOOD INFUSION AND FULLY AWAKENED AFTER THE NARCAN. THE CHEST TUBE OUTPUT REMAINED HIGH FOR ANOTHER 2 HOURS, HOWEVER, TAPERED OFF AFTER THE MEDICATION INTERVENTIONS, BLOOD, AND PLASMA/PLATELETS. SUBSEQUENTLY, NURSE EDUCATION WAS PERFORMED TO ENSURE THE USE OF THE ROLLER CLAMP IN FUTURE EVENTS, INSTEAD OF RELYING ON THE CHANNEL SAFETY LOCK (LOWER FITMENT) TO CAMP THE TUBING. THIS PATIENT WAS IN THE CICU AND DID NOT SUSTAIN LASTING HARM. PER BD'S INVESTIGATION OF THE SOURCE DEVICES, IT WAS DETERMINED THAT THE ROOT CAUSE OF THE REPORTED EVENT OF OVER INFUSION OF EPINEPHRINE WAS IDENTIFIED AS DUE TO A 3RD PARTY LATCH/SEAR. THE SOURCE DEVICE WAS OBSERVED TO HAVE A NON-BD BEZEL ASSEMBLY IDENTIFIED AS MANUFACTURED BY ELITE BIOMEDICAL SOLUTIONS. FDA SAFETY REPORT ID# (B)(4).