AQUAA 2700H

Description of Event or Problem

THE BIOMEDICAL TECHNICIAN (BIOMED) FOR A USER FACILITY REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE AQUAA REVERSE OSMOSIS (RO) SYSTEM ENCOUNTERED MULTIPLE DRY RUN PROTECTION ALARMS. ERROR CODES F-02-01-03 AND F¿02¿01¿05 WERE RECEIVED. THE BIOMED STATED DURING FOLLOW-UP THAT SMOKE WAS ENCOUNTERED FROM VALVE V41 WHEN ATTEMPTING TO PLACE THE RO SYSTEM IN EMERGENCY MODE. THE BIOMED RESPONDED TO THE SMOKE BY POWERING DOWN THE RO SYSTEM. THE BIOMED ALSO STATED THAT BLOWN FUSES WERE IDENTIFIED (FUSES F12 AND EITHER F20 OR F21 WHICH COULD NOT BE CONFIRMED BY THE BIOMED). VALVE V41 AND FUSES F12 AND F20 (OR F21) WERE REPLACED TO RESOLVE THE REPORTED MACHINE ISSUE. THE RO SYSTEM WAS RETURNED TO SERVICE FOLLOWING REPAIR. THERE WAS NO REPORTED HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THIS MALFUNCTION. NO PARTS WERE REPORTED TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO SAMPLE WAS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND MACHINE FILES WERE NOT PROVIDED FOR REVIEW. HOWEVER, THE REPORTED ISSUE WAS CONFIRMED BASED ON THE PROVIDED FEEDBACK. IT CAN BE INFERRED THAT THE MENTIONED ERROR CODE F-02-01-03 OCCURRED BASED ON DEFECTIVE VALVE V41. ACCORDING TO THE PROVIDED FEEDBACK, THE VALVE COIL ITSELF HAS A SHORT CIRCUIT (MEASURED RESISTANCE AROUND 0 OHM, NORMALLY AROUND 60-65 OHM). ACTIVATING THE VALVE COIL LED TO A SMOKING VALVE AND TRIPPING OF FUSE F12, AND F20 (OR F21) WHEN SWITCHING TO EMERGENCY MODE. THE ISSUE WAS SOLVED BY REPLACING THE VALVE V41. THE VALVE COIL V41 IS A SUPPLIER PART, AND WITHOUT A SAMPLE RETURN AND THE LOW FAILURE RATE NO SUPPLIER COMPLAINT WILL BE INITIATED. THE DEVICE ALARMED ACCORDING TO SPECIFICATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS COMPLETED. THE DEVICE HAS BEEN FOUND TO BE CONFORMING TO THE SPECIFICATIONS AND HAS BEEN RELEASED WITHOUT ANY DISCREPANCIES.