AQUABPLUS, B2, HF 1500 KIT
Received Oct 9, 2023 · Event occurred Sep 25, 2023
Report 3010850471-2023-00069 · MDR key 17896461
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
ADDITIONAL INFORMATION: B5 (REPORTED INSTALLATION OF REPLACEMENT MOTOR PROTECTION SWITCH AND POWER CONTACTOR CABLE CONNECTION) 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 CHARRED WIRES WERE IDENTIFIED ON THE STAGE 1 MOTOR PROTECTION SWITCH (MPS) OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THE REPORTED ISSUE WAS DISCOVERED DURING MACHINE REPAIR. THE BIOMED INITIALLY CONTACTED TECHNICAL SERVICES AFTER A PUMP P1 ALARM WAS RECEIVED DURING THE T1 TEST. ERROR CODE F¿04¿50¿04 WAS RECEIVED. THE BIOMED STATED THE THERMAL OVERLOAD RELAY TRIPPED AND NEEDED TO BE RESET. THERE WERE NO LOCAL POWER GRID ISSUES ON OR AROUND THE REPORTED EVENT DATE. THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. NO BLOWN FUSES WERE IDENTIFIED IN THE LOCAL POWER SUPPLY. THE BIOMED PLACED THE RO SYSTEM INTO EMERGENCY MODE IN ORDER TO RETURN THE RO TO SERVICE. A REPLACEMENT MPS AND WIRE CONNECTIONS BETWEEN THE MPS AND POWER CONTACTOR WERE ORDERED AND INSTALLED TO ADDRESS THE THERMAL DAMAGE. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANYONE AS A RESULT OF DISCOVERING THE THERMAL DAMAGE. NO ADDITIONAL INFORMATION IS PROVIDED.
Description of Event or Problem
A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT CHARRED WIRES WERE IDENTIFIED ON THE STAGE 1 MOTOR PROTECTION SWITCH (MPS) OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THE REPORTED ISSUE WAS DISCOVERED DURING MACHINE REPAIR. THE BIOMED INITIALLY CONTACTED TECHNICAL SERVICES AFTER A PUMP P1 ALARM WAS RECEIVED DURING THE T1 TEST. ERROR CODE F¿04¿50¿04 WAS RECEIVED. THE BIOMED STATED THE THERMAL OVERLOAD RELAY TRIPPED AND NEEDED TO BE RESET. THERE WERE NO LOCAL POWER GRID ISSUES ON OR AROUND THE REPORTED EVENT DATE. THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. NO BLOWN FUSES WERE IDENTIFIED IN THE LOCAL POWER SUPPLY. THE BIOMED PLACED THE RO SYSTEM INTO EMERGENCY MODE IN ORDER TO RETURN THE RO TO SERVICE. A REPLACEMENT MPS AND WIRE CONNECTIONS BETWEEN THE MPS AND POWER CONTACTOR WERE ORDERED AND INSTALLED TO ADDRESS THE THERMAL DAMAGE. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANYONE AS A RESULT OF DISCOVERING THE THERMAL DAMAGE. NO ADDITIONAL INFORMATION IS PROVIDED.
Additional Manufacturer Narrative
PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER A PHOTOGRAPH WAS PROVIDED BY THE CUSTOMER WHICH THE MANUFACTURER USED TO CONFIRM THE REPORTED ISSUE. THE FAILURE CAUSE CAN BE ATTRIBUTED TO BAD CONTACTING BETWEEN THE CABLE LUGS AND THEIR CONTACT PINS AT THE MOTOR PROTECTION SWITCH. MACHINES FILES WERE ALSO PROVIDED FOR REVIEW WHICH CONFIRMED THE REPORTED ERROR CODES AND TRIPPING OF THE THERMAL OVERLOAD SWITCH AS INTENDED.
Description of Event or Problem
A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT CHARRED WIRES WERE IDENTIFIED ON THE STAGE 1 MOTOR PROTECTION SWITCH (MPS) OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THE REPORTED ISSUE WAS DISCOVERED DURING MACHINE REPAIR. THE BIOMED INITIALLY CONTACTED TECHNICAL SERVICES AFTER A PUMP P1 ALARM WAS RECEIVED DURING THE T1 TEST. ERROR CODE F¿04¿50¿04 WAS RECEIVED. THE BIOMED STATED THE THERMAL OVERLOAD RELAY TRIPPED AND NEEDED TO BE RESET. THERE WERE NO LOCAL POWER GRID ISSUES ON OR AROUND THE REPORTED EVENT DATE. THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. NO BLOWN FUSES WERE IDENTIFIED IN THE LOCAL POWER SUPPLY. THE BIOMED PLACED THE RO SYSTEM INTO EMERGENCY MODE IN ORDER TO RETURN THE RO TO SERVICE. A REPLACEMENT MPS AND WIRE CONNECTIONS BETWEEN THE MPS AND POWER CONTACTOR WERE ORDERED TO ADDRESS THE THERMAL DAMAGE. AT THE TIME OF FOLLOW-UP THE REPLACEMENT PARTS HAD JUST ARRIVED AT THE FACILITY AND WERE PENDING INSTALLATION. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANYONE AS A RESULT OF DISCOVERING THE THERMAL DAMAGE. NO ADDITIONAL INFORMATION IS PROVIDED.
Additional Manufacturer Narrative
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.