DIASOL ACID CONCENTRATE

Description of Event or Problem

ACID CONCENTRATE SOLUTION FOR DIALYSIS WAS FILLED FROM A MIXING TANK INTO 1 GALLON BOTTLES. PRIOR TO STARTING THE MANUFACTURING OF THE PRODUCT AND THE FILING PROCESS, THE TANK AND THE FILLING LINES ARE RINSED WITH RO WATER. OUR WORK INSTRUCTIONS 70.009 REQUIRE THE OPERATOR TO PURGE THE FIRST 25-30 GALLONS OF LIQUID PRIOR TO STARTING THE ACTUAL FILLING OPERATION. THIS INSURES NO RESIDUAL WATER IS LEFT IN THE LINES AND THE ACID CONCENTRATE SOLUTION IS NOT DILUTED BY THE RESIDUAL RO WATER. OUR INVESTIGATION DETERMINED THAT THE EMPLOYEE OPERATING THE FILLING LINE FAILED TO PURGE THE LINES PRIOR TO STARTING THE ACTUAL FILLING PROCESS. THE FILLING OPERATION STARTED A YIELDED ACID CONCENTRATE MIXED WITH RO WATER WITH A SIGNIFICANTLY REDUCED CONCENTRATION OF ELECTROLYTES. FURTHERMORE, THE EMPLOYEE FAILED TO TAKE THE FIRST SAMPLE TO THE LAB AND BROUGHT A SAMPLE COLLECTED LATER THAT PASSED THE ACCEPTABILITY REQUIREMENTS. ALL BATCHES ARE TESTED FOR 3 SAMPLES. ALL PASSED THE ACCEPTABILITY REQUIREMENTS AND THE BATCH HAD BEEN RELEASED ORIGINALLY BASED ON THAT. UPON ARRIVING AT OUR CUSTOMER, THE ACID CONCENTRATE FAILED TO FUNCTION PROPERLY AND TRIGGERED THE DIALYSIS MACHINE TO ALARM AND STOP. THE DIALYSIS MACHINE ALARMED DUE TO THE LOW SODIUM CHLORIDE CONTENT, INCORRECT CONDUCTIVITY AND PH. THE CUSTOMER OPENED 7 DIFFERENT BOTTLES, ALL RESULTING IN THE DEVICE MALFUNCTION, WITH THE SAME PROBLEM OF LOW CONDUCTIVITY, AND THE MACHINE ALARMING. THE PRODUCT HAS NOT BEEN USED ON ANY PATIENTS. NO INJURY RESULTED. WE COLLECTED THE ENTIRE ORDER DELIVERED TOTALLING 27 CASES. WE TESTED THE 7 OPENED GALLONS RETURNED BY THE CUSTOMER AT AN OUTSIDE LAB. THE TEST INVOLVED MEASURING THE ELECTROLYTE CONCENTRATION IN THE SOLUTION. ALL 7 GALLONS SHOWED MUCH LOWER CONCENTRATION THAT THE ACCEPTABILITY RANGE. THREE ADDITIONAL RANDOM GALLONS WERE TESTED AS WELL. ALL 3 RESULTS MET THE ACCEPTABILITY CRITERIA. IN HOUSE LAB TESTED ALL 108 RETURNED GALLONS FOR SPECIFIC GRAVITY. 54 OF THEM HAD RESULTS BELOW THE ACCEPTABILITY RANGE. SINCE NORMALLY WE WOULD PURGE 25-30 GALLONS, WHEN MIXED WITH ACID CONCENTRATE, THE 54 GALLONS FOUND WITH REDUCED CONCENTRATIONS OF ELECTROLYTES MATCH THE EXPECTATION OF A MIX 25-30 WITH 25-30 GALLONS OF CONCENTRATE. BASED ON THIS CALCULATION AND THE RESULTS OF OUR TESTING, WE HAVE CONCLUDED THAT WE HAVE RECUPERATED THE ENTIRE AFFECTED QUANTITY OF PRODUCT.

Additional Manufacturer Narrative

DEVICE WAS NOT USED ON PATIENT. NO INJURY OCCURRED.