Description of Event or Problem · 1
THE USER FACILITY RECENTLY RECEIVED INFORMATION REASONABLY SUGGESTING THAT THE PATIENT MAY HAVE BEEN EXPOSED TO M. ABSCESSUS AS A RESULT OF THE USE OF A CARDIOQUIP HEATER COOLER DURING A SURGICAL PROCEDURE ON (B)(6) 2020. FOLLOWING THE (B)(6) 2020 PROCEDURE, THE PATIENT EXPERIENCED A NUMBER OF SERIOUS POST-SURGICAL COMPLICATIONS UNRELATED TO ANY INFECTION. DURING THE PATIENT'S LENGTHY POST-SURGICAL HOSPITALIZATION, VARIOUS CULTURES WERE POSITIVE FOR M. ABSCESSUS. THE PATIENT CONTINUED TO HAVE SERIOUS POST-SURGICAL COMPLICATIONS AND PASSED AWAY SEVERAL MONTHS LATER. THE CASE WAS DISCOVERED BY THE USER FACILITY AS PART OF AN INVESTIGATION INTO M. ABSCESSUS INFECTIONS IN TWO OTHER PATIENTS EXPOSED TO DIFFERENT MCH UNITS. (B)(6) LEARNED THAT A BLOOD CULTURE OBTAINED ON (B)(6) 2020 FROM A LUNG TRANSPLANT PATIENT RESULTED POSITIVE FOR M ABSCESSUS. THE PATIENT HAD UNDERGONE A CARDIAC PROCEDURE AT (B)(6) ON (B)(6) 2020 FACILITATED BY A CARDIOQUIP MCH DEVICE DESIGNATED "UNIT G" BY (B)(6). CULTURES FROM THE PATIENT AND THE MCH UNIT WERE COLLECTED FOR ADDITIONAL ANALYSIS. IN THE INTERIM, (B)(6) REVIEWED IN DETAIL RECORDS RELATED TO TRAINING OF LICENSED PERFUSIONISTS AND THE CLEANING/DISINFECTION PROCEDURES FOR THE MCH UNITS. THAT REVIEW REVEALED THAT (B)(6) PROCEDURES ADHERED TO AND, IN MANY ASPECTS EXCEEDED THE PROCESSES SET FORTH IN THE CARDIOQUIP IFUS. (B)(6) EXTRA PROCEDURES INCLUDE, BUT ARE NOT LIMITED TO THE FOLLOWING: IN ADDITION TO THE USE OF 0.2 ¿M FILTER TO PROVIDE DEMINERALIZED FILTERED WATER AS RECOMMENDED BY THE IFUS, (B)(6) ALSO USES A PREFILTER AHEAD OF THE 0.2 ¿M FILTER. ON A ROUTINE MONTHLY BASIS, (B)(6) DRAINS ALL WATER FROM THE UNITS AND DISINFECTS THE WATER TANKS MONTHLY, AS OPPOSED TO THE QUARTERLY BASIS SUGGESTED BY THE MANUFACTURER. DURING THIS PROCESS, IN ADDITION TO THE CLEANING AND DISINFECTION STEPS OUTLINED IN THE MANUFACTURER'S IFUS, (B)(6) ALSO LIFTS THE CONDENSER UNIT OUT FOR ADDITIONAL CLEANING. (B)(6) PROVIDES TRAINING FOR LICENSED PERFUSIONISTS TO CONDUCT THE PERIODIC CLEANING AND DISINFECTION PROCEDURES OF THE MCH UNITS. INITIAL AND ANNUAL COMPETENCIES ARE DOCUMENTED AND REVIEWED BY A SUPERVISOR. (B)(6) CONDUCTS MULTI-DISCIPLINARY REVIEWS TO KEEP UP-TO-DATE ON LITERATURE AND/OR ADVERSE EVENT REPORTS RELATED TO HEATER-COOLER MACHINES AND TO REVIEW ITS OWN PROCESSES AND DOCUMENTATION. (B)(6) REVIEW ESTABLISHED THAT ITS CLEANING, DISINFECTION, AND MAINTENANCE OF MCH UNIT G MET AND/OR EXCEEDED THE CARDIOQUIP IFUS AT ALL RELEVANT TIMES. (B)(6) SAMPLED MCH UNIT G AND A CULTURE FROM ONE LOCATION SAMPLED GREW M. IMMUNOGENUM. AS PART OF A LARGER INVESTIGATION, (B)(6) ALSO SAMPLED TWO OTHER MCH UNITS PRESENT IN HOSPITAL OPERATING ROOMS AND SUSPECTED OF BEING ASSOCIATED WITH EXPOSURE TO M. ABSCESSUS IN TWO OTHER PATIENTS. BECAUSE M. ABSCESSUS IS UBIQUITOUS IN THE ENVIRONMENT, (B)(6) SENT SAMPLES FROM THE MCH UNITS AND THE PATIENT CULTURES TO (B)(6) FOR GENOMIC ANALYSIS. ON (B)(6) 2021, (B)(6) RECEIVED RESULTS FROM THE LABORATORY DEMONSTRATING A GENETIC MATCH BETWEEN THIS PATIENT'S SAMPLE, THOSE OF THE OTHER TWO PATIENT SAMPLES, AND THE CULTURES FROM THE OTHER TWO MCH UNITS. A RECORDS REVIEW HAS REVEALED NO OTHER KNOWN M. ABSCESSUS CASES AMONG 127 SURGICAL PATIENTS EXPOSED TO UNIT G BETWEEN (B)(6) 2020 AND THE DATE THE UNIT WAS REMOVED FROM SERVICE. AN EPIDEMIOLOGICAL INVESTIGATION AND ENVIRONMENTAL CULTURES CONFIRMED MCH UNIT G AS THE MOST LIKELY SOURCE OF THE PATIENT'S EXPOSURE. GENETICALLY SIMILAR M. ABSCESSUS COLONIES WERE NOT ISOLATED FROM ENVIRONMENTAL CULTURES TAKEN FROM THE ROOM WHERE THE PATIENT UNDERWENT THE SURGERY. PGFE ANALYSIS CONFIRMED A GENETIC MATCH ON (B)(6) 2021 BETWEEN SAMPLES FROM THIS PT AND ORGANISM CULTURED FROM TWO OTHER MCH UNITS.