STERICHEK SENSITIVE TOTAL CHLORAMINES AND RESIDUAL CHLORINE REAGENT STRIPS

Description of Event or Problem

THIRTY-TWO (32) PTS INVOLVED. IN 2008, A DIALYSIS FACILITY NURSE REVIEWING ROUTINE WEEKLY LAB RESULTS FOR THE FACILITY'S DIALYSIS PTS NOTED A DROP IN HEMOGLOBIN FOR 32 PATIENTS. THE FACILITY ALLEGES THAT HACH TEST STRIPS USED TO DETECT CHLORINE HAD GIVEN FALSE NEGATIVE READINGS. THIRTY-ONE OF THE THIRTY-TWO PTS WERE REPORTEDLY DIAGNOSED WITH ANEMIA. ONE PT WAS REPORTEDLY DIAGNOSED WITH HEMOLYTIC ANEMIA AND MYOCARDIAL INFARCTION.

Additional Manufacturer Narrative

ADD'L LOT#: 7163. ADD'L DEVICE MANUFACTURE DATE: 06/2007. RESULTS: SAMPLE RETAINS FROM BOTH LOTS HAVE BEEN TESTED FOR CHLORINE AND CHLORAMINES. BOTH LOTS PASSED THE CHLORINE TEST AT ALL CONCENTRATIONS, AND PASSED THE CHLORAMINES AT CONCENTRATIONS 0.0 PPM, 0.1 PPM, AND 0.5 PPM. APPLIES TO LOT #7044 ONLY. TEST STRIPS FROM LOT #7044 MAY DETECT A LOWER CONCENTRATION OF CHLORAMINES AT THE 1.0 PPM CONCENTRATION. CONCLUSIONS: IN ACCORDANCE WITH THE AAMI STANDARD, THE MAXIMUM ALLOWABLE CHLORAMINES LEVEL IN WATER USED TO PREPARE DIALYSATE IS A CONCENTRATION OF 0.1 PPM (MG/L). REAGENT STRIPS FROM BOTH LOTS THEREFORE PROPERLY DETECT THE MAXIMUM ALLOWABLE CHLORAMINES LEVELS AS DIRECTED BY THE AAMI STANDARD. FURTHERMORE, THE DIRECTIONS FOR USE FOR THE STERICHEK SENSITIVE FEED WATER AND RINSE WATER REAGENT STRIPS STATES THE FOLLOWING: FEED WATER: A RESULT OF GREATER THAN 0.1 PPM INDICATES THAT THE FEED WATER TESTED SHOULD NOT BE USED TO PREPARE DIALYSATE, AND THE CARBON ABSORPTION MEDIA USED TO REMOVE EXCESS LEVELS OF CHLORAMINES MAY NEED TO BE REPLACED. RINSE WATER: A RESULT OF GREATER THAN 0.5 PPM INDICATES THAT AN ADD'L RINSE CYCLE SHOULD BE PERFORMED ON THE MACHINE. THEREFORE, THERE IS A MARGIN OF SAFETY BUILT INTO THE REAGENT STRIPS SHOULD THE REAGENT STRIPS DETECT A LOWER CONCENTRATION OF CHLORAMINES AT 1.0 PPM OR ABOVE.