DRY ACID 132 GALLON UNIT, ASSY TO SHIP

Additional Manufacturer Narrative

PLANT INVESTIGATION: THE RECIRCULATION MOTOR WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. UPON VISUAL INSPECTION OF THE RETURNED PART, IT WAS REVEALED THAT A STUCK ROTOR WAS CAUSED BY A MELTED PUMP HEAD. A RECORDS REVIEW WAS PERFORMED ON THE REPORTED SERIAL NUMBER. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO NON-CONFORMANCE'S, OR ANY ASSOCIATED REWORK IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE RELATED TO THE REPORTED EVENT. IN ADDITION, THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. UPON COMPLETION OF THE EVALUATION, THE REPORTED ISSUE WAS ABLE TO BE CONFIRMED.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SUPPORT (TS) THAT A DRY ACID 132-GALLON MIXER WAS NOT TRANSFERRING DURING DISSOLUTION MODE. THE BIOMED SAID THE RECIRCULATION PUMP WAS NOT INITIATING DURING TRANSFER MODE. IT WAS CONFIRMED THAT THE FILTER WAS CLEAN. THE BIOMED MEASURED 120 VOLTS AC AT THE PUMP CONNECTOR ON THE BACK OF THE CONTROL CONSOLE. UPON FOLLOW-UP IT WAS REPORTED THAT THE RECIRCULATION PUMP ASSEMBLY WAS REPLACED AND THIS RESOLVED THE ISSUE. THE MACHINE WAS PUT BACK IN SERVICE AND CONFIRMED TO BE FULLY OPERATIONAL. NO PHOTOS WERE AVAILABLE FOR REVIEW. THE RECIRCULATION MOTOR WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. UPON EVALUATION OF THE PART BY THE MANUFACTURER, IT WAS REVEALED THAT THE PUMP HEAD WAS MELTED.