HACH STERICHEK TOTAL CHLORINE REAGENT STRIPS

Description of Event or Problem

THIRTY THREE PTS INVOLVED. SEE ATTACHED PAGES 3 & 4. IN 2008, A FACILITY NURSE REVIEWING ROUTINE WEEKLY LAB RESULTS FOR THE FACILITY'S DIALYSIS PTS NOTED A DROP IN HEMOGLOBIN FOR APPROX 33 PTS. THE RELEVANT LABS ARE INCLUDED ON P4, FOR EACH PT. ON THE SAME DAY, ANOTHER FACILITY STAFF NOTED A POSSIBLE DISCOLORATION OF THE DIALYSIS LINES. THE FACILITY IMMEDIATELY DISCONTINUED ALL PT TREATMENTS AND INITIATED AN INVESTIGATION, WHICH REVEALED A SUSPECTED CHLORINE BREAK-THROUGH IN THE FACILITY'S WATER PURIFICATION SYSTEM. HACH TEST STRIPS USED TO DETECT CHLORINE HAD GIVEN FALSE NEGATIVE READINGS. THE FACILITY'S INVESTIGATION REVEALED THREE BOTTLES THAT WERE NOT REACTIVE TO CHLORINE. THE BOTTLES ORIGINATED FROM LOT #S 7163 AND 7044. WE BELIEVE 33 PTS WERE ADMITTED TO THE HOSP THROUGHOUT THE LAST 14 DAYS. MOST OF WHOM WERE REPORTEDLY DIAGNOSED WITH ANEMIA. AT LEAST ONE PT WAS REPORTEDLY DIAGNOSED WITH HEMOLYTIC ANEMIA AND MYOCARDIAL INFARCTION. LOT#-7044, EXPIRATION DATE-12/2008. SEE SCANNED PAGES.