Description of Event or Problem · 1
PT WITH HISTORY OF ERCP WITH STENTING (INCLUDING (B)(6) 2013) TRANSFERRED FROM AN OUTSIDE HOSPITAL WITH SEPTIC SHOCK ON (B)(6). BLOOD CULTURES DRAWN PRIOR TO TRANSFER POSITIVE FOR E. COLI, KLEBSIELLA PNEUMONIAE, AND CLOSTRIDIUM PERFRINGENS. PRIOR TO TRANSFER UNDERWENT ERCP ON (B)(6) WITH REMOVAL OF SLUDGE/STONES OCCLUDED STENT AND PLACEMENT OF 3 NEW PLASTIC STENTS. SHE WAS ABLE TO BE DISCHARGED ON (B)(6). ON (B)(6) 2016, (B)(6) WAS INFORMED BY THE PT'S DAUGHTER THAT SHE HAD PASSED AWAY IN THE LTAC ON (B)(6) 2016. DAUGHTER DID NOT DISCLOSE THE CAUSE OF DEATH BUT GIVEN THE PT'S RECENT HOSPITALIZATION AND CONDITION, (B)(6) BELIEVES IT IS LIKELY CORRELATED TO ERCP AND RESULTING ESBL E COLI INFECTIONS. THE ISOLATE IN THIS PT WAS IDENTICAL TO OTHER ESBL E. COLI THAT CAUSED INFECTIONS IN PTS WHO HAD UNDERGONE PROCEDURES WITH THE SAME DUODENOSCOPE, OLYMPUS TJF-Q180V-2202880. THIS ISSUE HAS BEEN REPORTED PREVIOUSLY TO THE MFR AND THE FDA. APPROPRIATE STATE HEALTH OFFICIALS HAVE BEEN NOTIFIED AS WELL. PRIOR TO PT ENCOUNTERS, THE SCOPE WAS BEING LEAK TESTED AND WASHED PER MFR GUIDELINES. FACILITY ALSO PERFORMED ATP TESTING. ON AUGUST 22, 2016 (B)(6) WAS INFORMED BY THE PT'S DAUGHTER THAT SHE HAD PASSED AWAY IN THE LTAC ON (B)(6) 2016. DAUGHTER DID NOT DISCLOSE THE CAUSE OF DEATH BUT GIVEN THE PT'S RECENT HOSPITALIZATION AND CONDITION, (B)(6) BELIEVES IT IS LIKELY CORRELATED TO ERCP AND RESULTING ESBL E COLI INFECTIONS.