Description of Event or Problem · 1
THE PT WAS A TWO-MONTH-OLD WITH A HYPOPLASTIC LEFT HEART. SHE UNDERWENT A NORWOOD OPERATION IN ANOTHER CITY, SINCE THE OPERATION IS NOT PERFORMED IN THE SAME CITY, ON FEB 6, 1998, SHE WAS ADMITTED TO THE PICU IN SEVERE CARDIOPULMONARY FAILURE. IN CASE YOU ARE NOT FAMILIAR WITH THIS CLINICAL SITUATION, A PRIMARY HEART LESION SUCH AS HERS IS FATAL.THE SURGERY IS VERY DIFFICULT, WITH A GENERALLY POOR OUTCOME. THE PT MANAGED TO SURVIVE THE NIGHT, BUT SHE WAS EXTREMELY UNSTABLE. WITH OXYGEN SATURATION IN THE MID 30S, SHE WAS DYING FROM SEVERE HYPOXIA. SINCE A CARDIAC ECHO SUGGESTED PULMONARY HYPERTENSION, IT WAS LEFT THAT INHALED NITRIC OXIDE OFFERED HER SOME CHANCE FOR SURVIVAL EVEN THOUGH THAT CHANCE WAS VERY SMALL. NITRIC OXIDE WAS DELIVERED AT 20 PARTS-PER-MILLION FOR 10 MINUTES AS PER THE PROTOCOL WITHOUT SIGNIFICANT CHANGES IN EITHER HEMODYNAMIC OR OXYGENATION PARAMETERS. WHEN THE 40 PARTS-PER-MILLION DOSE WAS DELIVERED, THE RESPIRATORY THERAPISTS HAD DIFFICULTY ACHIEVING THE REQUIRED NITRIC OXIDE CONCENTRATION. AS THE NITRIC OXIDE FLOW WAS ADJUSTED, THE PT DEVELOPED BRADYCARDIA, REQUIRING TREATMENT WITH EPINEPHRINE. THE NITRIC OXIDE DELIVERY, THEREFORE, WAS TERMINATED. WHEN THE PT RETURNED TO HER BASELINE CARDIO-PULMONARY STATUS, WHICH WAS VERY CRITICAL, HER OXYGEN SATURATIONS REMAINED BETWEEN 30 AND 50 PERCENT. THIS DEGREE OF HYPOXIA WAS STILL INCOMPATIBLE WITH LIFE AND THE CHILD EXPIRED LATER THAT EVENING. INITIALLY, FACILITY FELT THAT THE CHILD'S CARDIOPULMONARY INSTABILITY WHILE RECEIVING NITRIC OXIDE WAS DUE TO HER UNDERLYING DISEASE AND SEVERE HYPOXIA. FACILITY HAS SINCE BEEN INFORMED BY THE RESPIRATORY THERAPIST THAT FACILITY DID INDEED HAVE A TECHNICAL PROBLEM DURING THE NO DELIVERY. IT WAS DISCOVERED THAT THE NATION SAMPLING TUBE FROM THE VENTILATOR CIRCUIT TO THE NITRIC OXIDE ANALYZER WAS KINKED CAUSING THE ANALYZER TO UNDERESTIMATE THE NITRIC OXIDE CONCENTRATION. THE RESPIRATORY THERAPIST INCREASED THE NO FLOW IN ORDER TO ACHIEVE THE DESIRED NO CONCENTRATION AND THEREFORE INCREASED THE TIDAL VOLUME OF THE VENTILATOR BREATH. THIS LEAD TO AN INCREASE IN PEAK AIRWAY PRESSURES FOR A FEW BREATHS. THE INCREASED PRESSURE WAS QUICKLY NOTICED AND THE VENTILATOR WAS ADJUSTED, BUT THE PT DEVELOPED BRADYCARDIA AND THE NO WAS STOPPED. FACILITY WAS DISCUSSED THIS EVENT WITH THE PRIMARY INVESTIGATOR OF THE STUDY SO THAT HE CAN SUBMIT THE NECESSARY FDA REPORTS. HE STATED THAT HE PREVIOUSLY HAS NOT EXPERIENCED A KINK IN THE NATION TUBING. HE BELIEVES THAT, EVEN AT THE HIGHER DOSE OF NO THAT WAS BRIEFLY DELIVERED, THE NITRIC OXIDE WOULD NOT HAVE CAUSED THE OBSERVED BRADYCARDIA. FACILITY DID HAVE A TECHNICAL PROBLEM WITH THE DELIVERY SYSTEM AND THE RESPIRATORY THERAPY TECHNICIANS INVOLVED WITH THE STUDY HAVE TAKEN IMMEDIATE STEPS TO PREVENT THE PROBLEM IN THE FUTURE. THEY NOW TEST THE PATENCY OF THE SAMPLING TUBE AS PART OF THEIR ROUTINE. FACILITY IS EVALUATING EQUIPMENT FOR POSSIBLE PURCHASE THAT HAS AN ALARM WARNING OF SAMPLING TUBE OBSTRUCTION.