AQUAA 2700 A2 2700H
Received Feb 14, 2024 · Event occurred Oct 1, 2023
Report 3010850471-2024-00013 · MDR key 18704695
Device
Product problems
- Thermal Decomposition of Device
- Thermal Decomposition of Device
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
PLANT INVESTIGATION: THE MOTOR CONTACTOR WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE INNER CONTACTS OF THE CONTACTOR WERE NOTED TO HAVE SUSTAINED (THERMAL) DAMAGE. THE CONTACT PAD OF L3 IS DAMAGED AND WAS LIKELY THE CAUSE FOR THE STICKING CONTACTOR. AN ASYMMETRIC VOLTAGE OF THREE LINE CONDUCTORS CAUSES HIGHER CURRENT THAN USUAL AND WOULD RESULT IN THE DAMAGE OF THE INNER CONTACTS. MACHINE FILES AND PHOTOGRAPHS WERE ALSO PROVIDED. THIS SUPPORTING EVIDENCE CONFIRMS THE INITIAL REPORTED ISSUE OF THE STICKING CONTACTOR. THE CONTACTOR IS PRE-DAMAGED BY PREVIOUS ISSUES OF THIS DEVICE IN THE PAST . A ROOT CAUSE ANALYSIS FOR THIS FAILURE TYPE HAS BEEN INITIATED TO IDENTIFY FURTHER FACTORS BESIDE LINE FLUCTUATIONS THAT COULD CAUSE THIS ISSUE AND WHETHER COMPONENTS, LIKE THE CONTACTOR, ARE ADEQUATE. ACCORDING TO THE MOST RECENT RESULTS OF THE ROOT CAUSE ANALYSIS THE FAILURE CAUSE CAN MOST LIKELY BE ASSIGNED TO POWER FLUCTUATIONS AT A LINE CONDUCTOR OF THE LOCAL POWER SUPPLY, COMBINED WITH A DESIGN FLAW OF THE CONTACTOR AND INNER HEAT DEVELOPMENT INSIDE THE ELECTRICAL MONITOR.
Description of Event or Problem
A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT ERROR "F¿02¿02¿05" WITH MESSAGE "FAILURE: STAGE 2, RUN-DRY PROTECTION, PUMP STOP" WAS RECEIVED ON THE AQUAA REVERSE OSMOSIS (RO) SYSTEM. THE ERROR WAS RECEIVED DURING RING HEAT DISINFECTION FOLLOWING REPLACEMENT OF A LEAKING STAGE 1 PHP-CTRL. THE BIOMED FOUND THAT THE P1 PUMP WAS RUNNING DESPITE THE ALL VALUES READING FOR P1 = 0. THE BIOMED TRIED TO EXERCISE THE Q10 CONTACTOR, THINKING THAT THE CONTACTOR MAY BE STUCK IN THE CLOSED POSITION. THE BIOMED WAS UNABLE TO FIND AN ADEQUATE TEST POINT TO MEASURE FOR 24VDC ON THE CONTACTOR. AFTER THE HEAT DISINFECTION PROGRAM WAS COMPLETED, THE RO WAS COMPLETELY DE-ENERGIZED AND THE CONTACTOR WAS ABLE TO BE OPENED. THE BIOMED WAS SENT A REPLACEMENT CONTACTOR. THE BIOMED STATED DURING FOLLOW-UP THAT REPLACING THE MOTOR CONTRACTOR RESOLVED THE REPORTED ISSUE. THE SYSTEM WAS RETURNED TO SERVICE. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY INDIVIDUALS REGARDING THIS ISSUE. THE CONTACTOR WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. UPON EVALUATION, THERMAL DAMAGE WAS IDENTIFIED ON THE INNER CONTACTS.