AQUABPLUS, B2, HF 1000 KIT
Received Dec 5, 2023 · Event occurred Nov 14, 2023
Report 3010850471-2023-00104 · MDR key 18267848
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
Description of Event or Problem
A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DAMAGE WAS DISCOVERED ON THE WIRING OF THE MOTOR PROTECTION SWITCH OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE BIOMED STATED THE PLASTIC AROUND THE ENDS OF THE WIRES WAS VISIBLY DARKER FROM HEAT EXPOSURE. THE BIOMED INITIALLY CONTACTED TECHNICAL SERVICES WHEN THE RO SYSTEM POWERED OFF DURING THE T1 TEST. THROUGH TROUBLESHOOTING THE CAUSE WAS ISOLATED TO A DEFECT WITH THE MOTOR PROTECTION SWITCH THAT WOULD REQUIRE REPLACEMENT. THE RO SYSTEM WAS PLACED INTO EMERGENCY MODE USING STAGE 2 UNTIL THE ARRIVAL AND INSTALLATION OF THE REPLACEMENT PART. PART NUMBER M05000189 WAS PROVIDED TO THE CUSTOMER FOR THE MOTOR PROTECTION SWITCH. THE BIOMED CONFIRMED DURING FOLLOW-UP THAT REPLACING THE MOTOR PROTECTION SWITCH RESOLVED THE REPORTED ISSUE. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO PATIENT INVOLVED, NO HARM OR ADVERSE EVENTS REPORTED WITH THIS INCIDENT.
Additional Manufacturer Narrative
PLANT INVESTIGATION: NO SAMPLES WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE COMPLAINT AND THE REPORTED DEFICIENCY CAN BE CONFIRMED BY MEANS OF THE COMPLAINT INTAKE INFORMATION. THE MISSING MAINS PHASES AT THE MOTOR PROTECTION SWITCH WERE DETERMINED TO BE THE CAUSE OF THE TRIPPED SWITCH. THEY WERE TRIGGERED WHEN THE PUMP STARTED RUNNING AND THE MOTOR PROTECTION SWITCH TRIPPED AS INTENDED. POOR ELECTRICAL CONTACT WAS DETERMINED TO BE THE CAUSE OF THE THERMAL DAMAGE ON THE CABLE LUGS AT THE MOTOR PROTECTION SWITCH. THE THERMAL DAMAGE WAS CAUSED BY A TOO LOW CONTACT PRESSURE WHICH RESULTED IN A TOO HIGH CONTACT RESISTANCE AT THE BAD CONTACTED POINT AND A HIGH THERMAL POWER LOSS WAS INDICATED, NOTED AS THE THERMAL DAMAGE. THIS FAILURE PATTERN IS KNOWN. CORRECTIVE ACTIONS WERE DEFINED AND IMPLEMENTED. THE DESIGN OF THE CRIMPED CABLE LUG WAS CHANGED. THE AFFECTED DEVICE WAS BUILT BEFORE THE IMPLEMENTATION OF THE CAPA AND WAS STILL EQUIPPED WITH THE OLD DESIGN OF THE CRIMPED CABLE LUG AT TIME OF THE FAILURE.
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 (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DAMAGE WAS DISCOVERED ON THE WIRING OF THE MOTOR PROTECTION SWITCH OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE BIOMED STATED THE PLASTIC AROUND THE ENDS OF THE WIRES WAS VISIBLY DARKER FROM HEAT EXPOSURE. THE BIOMED INITIALLY CONTACTED TECHNICAL SERVICES WHEN THE RO SYSTEM POWERED OFF DURING THE T1 TEST. THROUGH TROUBLESHOOTING THE CAUSE WAS ISOLATED TO A DEFECT WITH THE MOTOR PROTECTION SWITCH THAT WOULD REQUIRE REPLACEMENT. THE RO SYSTEM WAS PLACED INTO EMERGENCY MODE USING STAGE 2 UNTIL THE ARRIVAL AND INSTALLATION OF THE REPLACEMENT PART. PART NUMBER M05000189 WAS PROVIDED TO THE CUSTOMER FOR THE MOTOR PROTECTION SWITCH. THE BIOMED CONFIRMED DURING FOLLOW-UP THAT REPLACING THE MOTOR PROTECTION SWITCH RESOLVED THE REPORTED ISSUE. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO PATIENT INVOLVED, NO HARM OR ADVERSE EVENTS REPORTED WITH THIS INCIDENT.