Description of Event or Problem · 1
IN 2007, A ROUTINE DISINFECTANT CYCLE WAS PERFORMED ON A COMPONENT OF THE DIALYSIS FACILITY'S WATER TREATMENT SYSTEM USING PURISTERIL 340. APPROXIMATELY 40 OTHER PTS WERE DIALYZED AT THE FACILITY THE FOLLOWING DAY. FOUR OF THESE PTS WERE HOSPITALIZED WITHIN 3 DAYS. THREE OF THE PTS HAD LAB RESULTS INDICATING HEMOLYSIS, AND THE FOURTH PT WAS DIAGNOSED WITH GI BLEEDING. PT WAS ULTIMATELY DIAGNOSED WITH CONGESTIVE HEART FAILURE, ACIDOSIS AND CARDIAC ARREST AND AFTER THE FAMILY DISCONTINUED LIFE SUPPORT, THE PT EXPIRED AT THE HOSPITAL 2 DAYS LATER. THE THREE OTHER PTS WERE TREATED AT THE HOSPITAL AND RELEASED. THE SUSPECTED ADVERSE EVENT WAS FIRST REPORTED ON 03/02/2007 VIA A CALL TO THE FACILITY CLINICAL MANAGER FROM THE HOSPITAL PATHOLOGIST INDICATING THAT SEVERAL PTS HAD PRESENTED TO THE ED WITH LAB WORK INDICATING HEMOLYSIS. THE CLINIC IMMEDIATELY CLOSED TO INVESTIGATE THE EVENT, INCLUDING THE POSSIBILITY THAT A RESIDUAL AMOUNT OF PURISTERIL 340 MAY HAVE BEEN INTRODUCED INTO THE DIALYSIS WATER SUPPLY. UPON CONCLUSION OF THE INVESTIGATION, THE CLINIC REOPENED 3 WEEKS LATER, AND HAS OPERATED CONTINUOUSLY SINCE WITHOUT INCIDENT.