Description of Event or Problem · 1
THE PT HAD THE INTRAGASTRIC BALLOON PLACED ON (B)(6) 2018. SHE PRESENTED TO A COMMUNITY HOSPITAL ON (B)(6) 2018 AFTER FEELING A "POPPING" SENSATION IN HER ABDOMEN OVERNIGHT, WITH PROGRESSIVE ABDOMINAL PAIN THE NEXT DAY. SHE WAS TRANSFERRED TO OUR FACILITY ON (B)(6) 2018. ON ADMISSION SHE WAS IN SEPTIC SHOCK AND HAD SUFFERED A LARGE POSTERIOR GASTRIC PERFORATION WITH FREE FLUID IN THE ABDOMEN. THE BALLOON WAS INTACT. OUR SURGICAL TEAM PERFORMED A SUBTOTAL GASTRECTOMY AS SHE HAD SIGNIFICANT NECROSIS OF THE ENTIRE POSTERIOR WALL OF HER STOMACH. SHE WAS SUBSEQUENTLY RE-OPERATED ON 4 ADD'L TIMES (B)(6) TO CONTROL HER INFECTION AND WAS LEFT WITH HER ESOPHAGUS AND DUODENUM IN DISCONTINUITY. RECONSTRUCTION COULD NOT BE ATTEMPTED AT THIS TIME. SHE EVENTUALLY RECOVERED FROM HER SEPSIS BUT COULD NOT BE WEANED OFF MECHANICAL VENTILATION. ON (B)(6) 2018, THE PT ONCE AGAIN WENT INTO SEPTIC SHOCK WITH LIKELY ANOTHER ABDOMINAL CATASTROPHE. SHE WAS TRANSITIONED TO COMFORT CARE AND DIED ON (B)(6) 2018. HER UNDERLYING CAUSE OF DEATH IS CATASTROPHIC GASTRIC PERFORATION. THIS DEVICE WAS REPLACED BY DR (B)(6) AT (B)(6), ON EITHER (B)(6) 2018. ADD'L INFO ABOUT THE SERIAL AND LOT NUMBERS, AS WELL AS SPECIFICS ABOUT IMPLANTATION, CAN BE OBTAINED FROM THAT OFFICE. OUR FACILITY ALSO SUBMITTED A FORM 3500 IN RESPONSE TO THIS EVENT. THAT REPORT WAS DATED (B)(6) 2018 AND THE REPORTER WAS DR (B)(6). THE SAME PT IDENTIFIER HAS BEEN USED ON THE TWO REPORTS.