AQUABPLUS, B2, HF 1500 KIT
Received Dec 26, 2023 · Event occurred Dec 8, 2023
Report 3010850471-2023-00108 · MDR key 18394928
Device
Product problems
- Thermal Decomposition of Device
- Thermal Decomposition of Device
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
PLANT INVESTIGATION: NO SAMPLES WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER THE MANUFACTURER CONFIRMED THE REPORTED EVENT BASED ON THE PROVIDED INFORMATION. THE COMPLAINT INVESTIGATION DETERMINED THAT THE LIKELY CAUSE OF THE THERMAL DAMAGE WAS A LOOSE ELECTRICAL CONTACT AT THE MOTOR PROTECTION SWITCH. IN SUCH AN INSTANCE THE PUMP WILL RUN ONLY WITH TWO LINE CONDUCTORS, RESULTING IN HIGHER CURRENT AND HIGHER THERMAL ENERGY. THE CABLE LUGS AT THE MOTOR PROTECTION SWITCH CAN GET OVERHEATED AND DISCOLORED BY THE RELEASED THERMAL ENERGY AT THE BAD ELECTRICAL CONTACT. THIS IS A KNOWN FAILURE. CORRECTIVE ACTIONS HAVE BEEN DEFINED AND IMPLEMENTED FOR THIS KNOWN FAILURE. THE WIRING WAS REDESIGNED AND RELEASED. THE DEVICE WAS BUILT BEFORE THE IMPROVEMENT OF THE DESIGN. IN THIS INSTANCE THE SWITCH AND CONNECTED WIRING WERE REPLACED TO RESOLVE THE REPORTED ISSUE. IT IS RECOMMENDED, IF NOT ALREADY DONE, TO REPLACE THE MOTOR PROTECTION SWITCH AND BLACK CONNECTION WIRES AGAINST THE IMPROVED DESIGN IN STAGE 1 AND STAGE 2.
Description of Event or Problem
A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS THAT THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. L1 OF THE STAGE 1 MOTOR PROTECTION SWITCH (MPS) WAS BLACKENED. THE THERMAL DAMAGE WAS DISCOVERED DURING MACHINE REPAIR. THE BIOMED INITIALLY CONTACTED FRESENIUS FOR TROUBLESHOOTING ASSISTANCE AFTER RECEIVING ERROR CODE F¿04¿51¿04 AND THE MESSAGE "FAILURE: T1 TEST, PUMP P1S DEFECTIVE." THE BIOMED REPLACED THE STAGE 1 MPS THEN RECEIVED ERROR CODE W¿02¿51¿03 AND THE MESSAGE "CONCENTRATE PRESSURE TOO LOW." THE RO SYSTEM WAS RUNNING IN STAGE 2 EMERGENCY MODE. THE WATER HARDNESS SUPPLIED TO THE RO SYSTEM WAS 20 PARTS PER MILLION (PPM). FRESENIUS RECOMMENDED RESOLVING THE WATER SOFTENER ISSUE AS 20 PPM IS TOO HIGH. ONCE THE SOFTENER ISSUE IS RESOLVED, THE BIOMED WAS ADVISED TO DECALCIFY THE STAGE 1 MEMBRANES OR REPLACE THEM. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER A RESPONSE WAS NOT RECEIVED. THERE WAS NO PATIENT INVOLVEMENT NOR REPORTED PERSONAL HARM TO ANY INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.
Description of Event or Problem
A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS THAT THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. L1 OF THE STAGE 1 MOTOR PROTECTION SWITCH (MPS) WAS BLACKENED. THE THERMAL DAMAGE WAS DISCOVERED DURING MACHINE REPAIR. THE BIOMED INITIALLY CONTACTED FRESENIUS FOR TROUBLESHOOTING ASSISTANCE AFTER RECEIVING ERROR CODE F¿04¿51¿04 AND THE MESSAGE "FAILURE: T1 TEST, PUMP P1S DEFECTIVE." THE BIOMED REPLACED THE STAGE 1 MPS THEN RECEIVED ERROR CODE W¿02¿51¿03 AND THE MESSAGE "CONCENTRATE PRESSURE TOO LOW." THE RO SYSTEM WAS RUNNING IN STAGE 2 EMERGENCY MODE. THE WATER HARDNESS SUPPLIED TO THE RO SYSTEM WAS 20 PARTS PER MILLION (PPM). FRESENIUS RECOMMENDED RESOLVING THE WATER SOFTENER ISSUE AS 20 PPM IS TOO HIGH. ONCE THE SOFTENER ISSUE IS RESOLVED, THE BIOMED WAS ADVISED TO DECALCIFY THE STAGE 1 MEMBRANES OR REPLACE THEM. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER A RESPONSE WAS NOT RECEIVED. THERE WAS NO PATIENT INVOLVEMENT NOR REPORTED PERSONAL HARM TO ANY INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.
Additional Manufacturer Narrative
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.