AQUABPLUS, B2, HF 1500 KIT
Received Jul 2, 2024 · Event occurred Jun 29, 2024
Report 3010850471-2024-00058 · MDR key 19656465
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
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
Description of Event or Problem
A USER FACILITY BIOMEDICAL TECHNICIAN REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE STAGE 1 MOTOR PROTECTION SWITCH (MPS) AND CONNECTED WIRES WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM WERE BURNED. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THE REPORTED ISSUE WAS DISCOVERED AFTER THE RO SYSTEM FAILED THE T1 TEST. ERROR ¿F¿04¿51¿04 FAILURE: T1 TEST, PUMP P1 DEFECTIVE¿ WAS RECEIVED. NO BLOWN FUSES WERE IDENTIFIED. THE THERMAL OVERLOAD RELAY DID NOT TRIP. THERE WERE NO LOCAL POWER GRID ISSUES OR ELECTRICAL STORMS IN THE AREA ON OR AROUND THE REPORTED EVENT DATE. THE STAGE 1 MPS AND WIRING HARNESS WERE REPLACED TO RESOLVE THE THERMAL DAMAGE. THE CONCENTRATE PRESSURES ON BOTH ROS WERE ALSO FOUND TO BE LOW (P1-5.4 & P2-4.0). THE CONCENTRATE PRESSURES WERE ADJUSTED IN ORDER TO PASS THE T1 TEST. THE RO SYSTEM WAS RETURNED TO SERVICE. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE.
Description of Event or Problem
A USER FACILITY BIOMEDICAL TECHNICIAN REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE STAGE 1 MOTOR PROTECTION SWITCH (MPS) AND CONNECTED WIRES WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM WERE BURNED. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THE REPORTED ISSUE WAS DISCOVERED AFTER THE RO SYSTEM FAILED THE T1 TEST. ERROR ¿F¿04¿51¿04 FAILURE: T1 TEST, PUMP P1 DEFECTIVE¿ WAS RECEIVED. NO BLOWN FUSES WERE IDENTIFIED. THE THERMAL OVERLOAD RELAY DID NOT TRIP. THERE WERE NO LOCAL POWER GRID ISSUES OR ELECTRICAL STORMS IN THE AREA ON OR AROUND THE REPORTED EVENT DATE. THE STAGE 1 MPS AND WIRING HARNESS WERE REPLACED TO RESOLVE THE THERMAL DAMAGE. THE CONCENTRATE PRESSURES ON BOTH ROS WERE ALSO FOUND TO BE LOW (P1-5.4 & P2-4.0). THE CONCENTRATE PRESSURES WERE ADJUSTED IN ORDER TO PASS THE T1 TEST. THE RO SYSTEM WAS RETURNED TO SERVICE. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE.
Additional Manufacturer Narrative
PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER THE MANUFACTURER CONFIRMED THE REPORTED ISSUE BASED ON THE INFORMATION AND PHOTOGRAPH PROVIDED BY THE CUSTOMER. THE MANUFACTURER DETERMINED THAT THE THERMAL DAMAGE OCCURRED DUE TO HIGH CONTACT RESISTANCE AND THERMAL POWER LOSS AT AS THE RESULT OF POOR ELECTRICAL CONTACT AT THE MOTOR PROTECTION SWITCH. THE HIGH CURRENTS RESULTED IN THERMAL DAMAGE TO THE THE WIRES AND CABLE LUGS. THIS IS A KNOWN FAILURE. CORRECTIVE ACTIONS HAVE BEEN DEFINED AND IMPLEMENTED. THE CRIMPED CABLE LUG HAS BEEN RE-DESIGNED. IN THIS CASE, THE SWITCH AND WIRING HAVE BEEN REPLACED TO RESOLVE THE REPORTED ISSUE.