AQUAA 2700 A2 2700H
Received Jul 30, 2024 · Event occurred Jul 24, 2024
Report 3010850471-2024-00062 · MDR key 19861246
Device
Product problems
- Melted
- Melted
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
Description of Event or Problem
A FRESENIUS FIELD SERVICE TECHNICIAN (FST) CAME ONSITE AFTER THE AQUAA REVERSE OSMOSIS (RO) SYSTEM DISPLAYED ERRORS "W¿02¿01¿08 WARNING: FAILURE TO REACH RINSE VOLUME" AND "W-02-01-16: PERMEATE PRESSURE BELOW ALARM LIMIT" UPON POWER UP. THERE WAS NO POWER SURGE OR BLACKOUT AT THE FACILITY. THERE WAS NO PATIENT INVOLVEMENT. THE FRESENIUS FST EVALUATED THE SYSTEM AND DISCOVERED ONE OF THE THREE WIRES CONNECTED TO A DEFECTIVE MOTOR PROTECTION SWITCH AND CONTACTOR RELAY WAS MELTED. THE MOTOR PROTECTION SWITCH, CONTACTOR RELAY, AND 3 JUMPER WIRES FROM THE POWER SWITCH TO THE CONTACTOR RELAY WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE MACHINE POWERED ON WITHOUT ISSUE. THE MACHINE PASSED FUNCTIONAL TESTING AND THE PRESSURES WERE VERIFIED TO BE WITHIN RANGE. THE MACHINE RAN FOR THREE HOURS WITHOUT ISSUE. THE RO SYSTEM WAS RETURNED TO THE CUSTOMER TO BE PLACED BACK INTO SERVICE.
Description of Event or Problem
A FRESENIUS FIELD SERVICE TECHNICIAN (FST) CAME ONSITE AFTER THE AQUAA REVERSE OSMOSIS (RO) SYSTEM DISPLAYED ERRORS "W¿02¿01¿08 WARNING: FAILURE TO REACH RINSE VOLUME" AND "W-02-01-16: PERMEATE PRESSURE BELOW ALARM LIMIT" UPON POWER UP. THERE WAS NO POWER SURGE OR BLACKOUT AT THE FACILITY. THERE WAS NO PATIENT INVOLVEMENT. THE FRESENIUS FST EVALUATED THE SYSTEM AND DISCOVERED ONE OF THE THREE WIRES CONNECTED TO A DEFECTIVE MOTOR PROTECTION SWITCH AND CONTACTOR RELAY WAS MELTED. THE MOTOR PROTECTION SWITCH, CONTACTOR RELAY, AND 3 JUMPER WIRES FROM THE POWER SWITCH TO THE CONTACTOR RELAY WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE MACHINE POWERED ON WITHOUT ISSUE. THE MACHINE PASSED FUNCTIONAL TESTING AND THE PRESSURES WERE VERIFIED TO BE WITHIN RANGE. THE MACHINE RAN FOR THREE HOURS WITHOUT ISSUE. THE RO SYSTEM WAS RETURNED TO THE CUSTOMER TO BE PLACED BACK INTO SERVICE.
Additional Manufacturer Narrative
PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER, THE REPORTED EVENT WAS CONFIRMED USING THE PHOTOGRAPHS PROVIDED BY THE CUSTOMER. THE REPORTED ISSUE IS A KNOWN FAILURE. CORRECTIVE ACTIONS ARE IN PROGRESS. THE LATEST FINDINGS FROM THE INVESTIGATION INDICATE TWO POSSIBLE REASONS FOR THIS FAILURE: (1) THE FACILITY POWER SUPPLY OR (2) THE ELECTRICAL DESIGN OF THE MOTOR PROTECTION SWITCH AND WIRING. A BAD ELECTRICAL CONTACT AT THE MOTOR PROTECTION SWITCH COULD RESULT IN INCREASED CONTACT RESISTANCE AND INCREASED THERMAL ENERGY AT THE CONTACTS POINTS. THE SPRING CLAMP CONNECTION AT THE MOTOR PROTECTION SWITCH WOULD OVERHEAT AND DISCOLOR FROM THE RELEASED THERMAL ENERGY AT THE BAD ELECTRICAL CONTACT. ACCORDING TO THE INTAKE INFORMATION, THE ISSUE WAS SOLVED BY REPLACING THE CONTACTOR, MOTOR PROTECTION SWITCH AND THE WIRING.