Description of Event or Problem · 1
PATIENT WAS ADMITTED FOR SURGICAL LAPAROSCOPIC PLACEMENT OF A BURIED CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) CATHETER FOR DIALYSIS. FOLLOWING APPLICATION OF STANDARD AMERICAN SOCIETY OF ANESTHESIOLOGISTS (ASA) MONITORS AND PLACEMENT OF AN ARTERIAL CATHETER, THE PATIENT UNDERWENT A RAPID SEQUENCE INDUCTION AND INTUBATION. THE ORAL ENDOTRACHEAL TUBE (ETT) WAS CONNECTED TO THE BREATHING CIRCUIT ON THE DRAEGER APOLLO ANESTHESIA MACHINE. DESPITE HIGH FLOW OXYGEN AND THE MACHINE BEING ON MANUAL/SPONTANEOUS MODE, POSITIVE PRESSURE VENTILATION COULD NOT BE ACHIEVED. THE CIRCUIT WAS CHECKED FOR LEAKS AND A RAPID DIRECT LARYNGOSCOPY WAS PERFORMED WHICH CONFIRMED PLACEMENT OF THE ETT IN THE TRACHEA. DUE TO THE PATIENT'S VERY POOR CARDIOPULMONARY FUNCTION, HE BECAME HYPOXIC (OXYGEN SATURATION OF 70 PERCENT), HYPOTENSIVE (55 MMHG SYSTOLIC OVER 20 MMHG DIASTOLIC) AND BRADYCARDIC (HEART RATE OF 27). EPINEPHRINE 100 MCG WAS GIVEN AND OXYGENATED VENTILATION WAS ESTABLISHED WITH STAND-ALONE OXYGEN TANK AND AMBU-BAG. OXYGENATION QUICKLY IMPROVED WITH PRESENCE OF BILATERAL BREATH SOUNDS. DUE TO EPINEPHRINE ADMINISTRATION, THE HEART RATE INCREASED TO 180 BPM. AN ARTERIAL CATHETER REVEALED A SYSTOLIC BLOOD PRESSURE (SBP) IN THE 170'S. THIS ALLOWED FOR RATE CONTROL TO BE ACHIEVED CHEMICALLY WITH ESMOLOL AND LIDOCAINE WHICH BROUGHT THE HEART RATE DOWN TO HIS NORMAL RHYTHM WHICH WAS VENTRICULAR PACED AT 70 BEATS PER MINUTE (BPM). THE PATIENT WAS PLACED ON VOLUME CONTROL VENTILATION THROUGH THE DRAEGER APOLLO WHICH WORKED NORMALLY.MULTIPLE ATTEMPTS WERE MADE TO SWITCH TO MANUAL VENTILATION AND PROVIDE MANUAL BREATHS WITH DRAEGER REPRESENTATIVE PRESENT, BUT FORWARD FRESH GAS FLOW TO THE PATIENT COULD NOT BE ACHIEVED. THE CLIC CANISTER WAS NOT REMOVED FROM THE ANESTHESIA MACHINE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT HIS OR AND PACU STAY. THE DRAEGER CLINICAL EDUCATOR STATED THAT THE PROBLEM WAS MECHANICAL. HOWEVER, THE CASE WAS COMPLETED WITH THE SAME MACHINE THAT WOULD NOT ALLOW MANUAL VENTILATION BY USING VOLUME CONTROL VENTILATION. PATIENT WAS EVALUATED BY A CARDIOLOGIST POST-OPERATIVELY, WHO STATED THAT DURING THE OPERATION THE PATIENT APPARENTLY WENT INTO A WIDE-COMPLEX TACHYARRHYTHMIA. PATIENT HAS AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IMPLANT AND PRE-OPERATIVE EJECTION FRACTION OF 20 PERCENT. PATIENT WAS DISCHARGED TO HOME IN STABLE CONDITION THE DAY AFTER SURGERY. ELECTRONIC LOG FILES OF THIS MACHINE REVEALED A SELF-TEST AND LEAK/COMPLIANCE CHECK WAS DONE AT 6:26 AM PRIOR TO THE FIRST CASE OF THE DAY. A 4 CASES WERE DONE WITH THIS MACHINE ON THE DAY OF THE REPORTED EVENT. DURING CASE 4, VENTLOGGER DATA SHOWS MINIMAL OR NO READINGS FOR CARBON DIOXIDE, POSITIVE END EXPIRATORY PRESSURE (PEEP) AND MINUTE VOLUME VALUES. MUTIPLE MODE CHANGES WERE MADE DURING THE CASE. SELF TESTS AND LEAK/COMPLIANCE CHECKS WERE DONE ONLY PRIOR TO THE FIRST CASE OF THE DAY, NOT EACH CASE. EQUIPMENT LOGS OF THE APOLLO ARE AVAILABLE. A SIMILAR CASE REPORT OF FAILURE TO VENTILATE WITH THE DRAEGER APOLLO ANESTHESIA WORKSTATION WAS PUBLISHED IN THE JOURNAL OF ANESTHESIA, V 114 NO. 5 (MAY 2011) P. 1238-1242. MEDSUN DATABASE WAS QUERIED FOR SIMILAR REPORTED EVENTS. A SIMILAR CASE WITH FAILURE TO VENTILATE WAS REPORTED BY ANOTHER MEDSUN HOSPITAL. ======================MANUFACTURER RESPONSE FOR ANESTHESIA MACHINE, DRAEGER APOLLO ANESTHESIA MACHINE (PER SITE REPORTER)======================AT THE CONCLUSION OF THE CASE, THE MACHINE WAS MOVED TO ANOTHER ROOM AND WAS EXAMINED BY A DRAEGER TECHNICIAN WHO WAS ON-SITE TO EXAMINE ANOTHER DRAEGER APOLLO ANESTHESIA MACHINE. HE REMOVED A CLIC CANISTER FROM THE DRAEGER APOLLO ANESTHESIA MACHINE. SERVICE REPORT FROM DRAEGER COMPLETED SEVERAL DAYS AFTER THE REPORTED EVENT, CONFIRMED THE REPORTED ERROR AND NOTED THAT THE CLIC CANISTER HAD A HOLE IN THE BOTTOM OF IT. THE HOLE WAS NOT PRESENT DURING OR IMMEDIATELY AFTER THE SURGERY. THE HOLE CAUSED GAS TO FLOW OUT INSTEAD OF TO THE PATIENT. DRAEGER REPLACED THE CANISTER WITH A KNOWN GOOD CANISTER AND VERIFIED THAT THE DEVICE PASSED A LEAK TEST AND WAS ABLE TO SWITCH FROM VOLUME MODE TO MANUAL/SPONTANEOUS MODE. LETTER FROM DRAEGER REGULATORY AFFAIRS COMPLIANCE SPECIALIST STATED THE PROBLEM WITH APOLLO NOT BUILDING PRESSURE IN MANUAL/SPONTANEOUS MODE WAS DUE TO A SYSTEM LEAK THAT WAS THE RESULT OF A BROKEN CLIC ABSORBENT CANISTER. PRE-USE CHECKS FOR THE APOLLO ARE BEING PERFORMED AT THE START OF THE DAY, BUT NOT PRIOR TO EACH CASE OF THE DAY AS DRAEGER RECOMMENDS.