Description of Event or Problem · 1
THE PATIENT WAS TRANSFERRED TO (B)(6) FOR MASSIVE HEMOPTYSIS. ONCE TRANSFERRED, THE PATIENT WAS TAKEN TO THE OPERATING SUITE WHERE INITIALLY LARYNGEAL MASK AIRWAY ACCESS WAS OBTAINED FOR GENERAL ANESTHESIA. DUE TO THE EXCESSIVE BLEEDING THE LMA WAS REPLACED BY AN ENDOTRACHEAL TUBE OF 8.5 MM. THIS ET TUBE WAS SUFFICIENT SIZE FOR USE OF SPRAY CRYOTHERAPY. THE PHYSICIAN BIOPSIED THE APPARENT TUMOR MASS SEVERAL TIMES AT THE SURFACE AND THEN DEEPER INTO THE TUMOR FOR DIAGNOSIS OF THE TUMOR. THE PHYSICIAN DECIDED TO USE SPRAY CRYOTHERAPY IN AN ATTEMPT TO STOP THE BLEEDING FROM THE TUMOR AND APPLIED THREE SEPARATE SCT ABLATIONS TO THE TUMOR SURFACE WITH GOOD RESPONSE OF BLEEDING CONTROL. EACH SPRAY WAS PERFORMED SUCH THAT SURFACE FREEZING WAS ACHIEVED AND THEN HELD WITH A POST TISSUE FROST DURATION OF FIVE SECONDS; THE TOTAL FREEZE TIME RECORDED IN THE DATA LOG FILES WAS 25 TO 28 SECONDS. THROUGHOUT THE PROCEDURE, THE TREATING PHYSICIAN ASKED FOR THE ANESTHESIA CIRCUIT TO BE DISCONNECTED AND THE ENDOTRACHEAL CUFF DEFLATED AT THE TIME OF ONSET OF TISSUE FROST, APPROXIMATELY 20 SECOND AFTER SPRAY WAS INITIATED. THESE MANEUVERS WERE NOT PERFORMED AT THE ONSET OF SCT USE, AS IS MANDATED BY THE COMPANY DURING DIDACTIC AND ANIMAL LAB TRAINING AS COLD NITROGEN GAS CONTINUES TO EXPAND EVEN THOUGH FROST HAS NOT DEVELOPED. THE INABILITY TO PROPERLY VENT THE NITROGEN GAS IS KNOWN TO LEAD TO PNEUMOTHORAX. ONCE THE CIRCUIT WAS OFF AND THE CUFF WAS DOWN, THERE WAS WHAT APPEARED TO BE PASSIVE VENTING OF COLD NITROGEN GAS GIVEN THAT THERE WAS COLD MIST NOTED TO BE FREELY EXITING VIA THE ET TUBE AND THERE WAS NO CHEST EXPANSION. DURING THE FIRST THREE SPRAY CRYOTHERAPY SESSIONS THE PATIENT WAS STABLE WITHOUT BRADYCARDIA OR HYPOXIA. IT WAS DETERMINED THAT A FOURTH SCT ABLATION WAS REQUIRED TO COMPLETE HEMOSTASIS AND DURING THAT SCT IT WAS NOTED THAT THE PATIENT HAD SUBCUTANEOUS EMPHYSEMA IN THE NECK AND FACE REGION. DESPITE APPARENT STABILITY OF THE PATIENT THE PHYSICIAN ELECTED TO PLACE BILATERAL CHEST TUBES FOR SUSPECTED PNEUMOTHORAX. DURING PLACEMENT THE PATIENT EXPERIENCED A DROP IN BLOOD PRESSURE TO A SYSTOLIC IN THE 80S TO 90S AND BRADYCARDIA TO THE 50 TO 60 BEATS PER MINUTE. BESIDES THE RIGHT PLEURAL FLUID EMANATING FROM THE CHEST TUBES, IT WAS INDICATED THAT THERE WAS EVIDENCE OF AIR FROM BOTH CHEST TUBES. ONCE THE SYSTOLIC PRESSURE BY EXTERNAL CUFF WAS NOTED TO DROP TO THE 60S THE PATIENT UNDERWENT RESUSCITATION WITH ATROPINE AND EPINEPHRINE ADMINISTRATION, PLACEMENT OF AN ARTERIAL LINE AND DESPITE CONTINUED CARDIAC ELECTRICAL ACTIVITY OF A HEART RATE IN 40S CHEST COMPRESSION WAS INITIATED. IT WAS NOTED THAT CHEST COMPRESSION WAS RESULTING IN A SYSTOLIC BLOOD PRESSURE OF APPROXIMATELY 100. ALTHOUGH NOT NOTED EXACTLY AT SOME POINT IN THE RESUSCITATION THE PATIENT BECAME ASYSTOLIC. SEVERAL ATTEMPTS AT CARDIOVERSION WERE PERFORMED BUT THE PATIENT DID NOT RE-ESTABLISH A CARDIAC RHYTHM AND THE PATIENT WAS PRONOUNCED DEAD. THERE WAS NO CLINICAL EVIDENCE OF DIRECT CAUSE OF DEATH AND THE PATIENT'S FAMILY REFUSED AUTOPSY. IT WAS THE OPINION OF PHYSICIAN THAT SCT CONTRIBUTED TO THE PATIENT'S CLINICAL COURSE AND SUBSEQUENT DEMISE ALTHOUGH THE COURSE WAS FURTHER COMPLICATED BY THE PATIENT'S UNDERLYING DISEASE STATE AND THE APPARENT DELAY ON THE PART OF THE TREATING PHYSICIAN IN ACHIEVING ADEQUATE INITIAL GAS EGRESS DURING THE INITIAL PORTIONS OF THE SCT PROCEDURES.