AQUABPLUS, B2, HF 1500 KIT
Received Dec 26, 2024 · Event occurred Dec 23, 2024
Report 3010850471-2024-00110 · MDR key 21020752
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
Description of Event or Problem
THE BIOMEDICAL TECHNICIAN (BIOMED) FOR A USER FACILITY REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DECOMPOSITION WAS DISCOVERED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE DAMAGE WAS IDENTIFIED DURING TROUBLESHOOTING. ERROR "F-04-51-04 - PUMP P1S DEFECTIVE" WAS ENCOUNTERED DURING THE T1 TEST AND THE STAGE 2 PUMP WOULD NOT INITIATE. UPON EVALUATION, IT WAS IDENTIFIED THAT THE WIRES ON THE STAGE 2 MOTOR PROTECTION SWITCH (MPS) APPEARED "BURNED/SCORCHED." NO BURNING SMELL, SPARK, FLAME, OR ARCING WAS REPORTED. THE THERMAL OVERLOAD RELAY WAS NOT TRIPPED. LIMITED INFORMATION WAS AVAILABLE UPON FOLLOW-UP. THE CONNECTORS AND MPS WERE REPLACED TO RESOLVE THE REPORTED ISSUE. NO SAMPLE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO 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 REPORTED ISSUE WAS CONFIRMED BY THE MANUFACTURER BY MEANS OF THE PHOTOGRAPH AND INFORMATION PROVIDED BY THE CUSTOMER. THE MANUFACTURER DETERMINED THE CAUSE OF THE REPORTED ISSUE TO BE AN INADEQUATE DESIGN OF THE CABLE LUGS, WHICH RESULTED IN BAD ELECTRICAL CONTACTING AT THE CABLE/CABLE LUG ATTACHED TO THE MOTOR PROTECTION SWITCH. THIS FAILURE IS A KNOWN ISSUE. CORRECTIVE ACTIONS HAVE BEEN DEFINED. A DESIGN CHANGE FOR A DIFFERENT MOTOR PROTECTION SWITCH TYPE AND ELECTRICAL CONNECTION IS GOING TO BE IMPLEMENTED. THE NEW DESIGN IS CURRENTLY NOT AVAILABLE FOR THE US MARKET. ACCORDING TO THE PROVIDED INFORMATION, THE CONCERNED CONNECTORS AND THE MOTOR PROTECTION SWITCH WERE REPLACED TO RESOLVE THE ISSUE. IT IS RECOMMENDED, TO CHECK AND REPLACE IF REQUIRED THE WIRING AND THE MOTOR PROTECTION SWITCH IN STAGE 1 AND STAGE 2 TO AVOID ADDITIONAL FAILURES.
Description of Event or Problem
THE BIOMEDICAL TECHNICIAN (BIOMED) FOR A USER FACILITY REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DECOMPOSITION WAS DISCOVERED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE DAMAGE WAS IDENTIFIED DURING TROUBLESHOOTING. ERROR "F-04-51-04 - PUMP P1S DEFECTIVE" WAS ENCOUNTERED DURING THE T1 TEST AND THE STAGE 2 PUMP WOULD NOT INITIATE. UPON EVALUATION, IT WAS IDENTIFIED THAT THE WIRES ON THE STAGE 2 MOTOR PROTECTION SWITCH (MPS) APPEARED "BURNED/SCORCHED." NO BURNING SMELL, SPARK, FLAME, OR ARCING WAS REPORTED. THE THERMAL OVERLOAD RELAY WAS NOT TRIPPED. LIMITED INFORMATION WAS AVAILABLE UPON FOLLOW-UP. THE CONNECTORS AND MPS WERE REPLACED TO RESOLVE THE REPORTED ISSUE. NO SAMPLE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE.
Additional Manufacturer Narrative
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.