AQUABPLUS, B2, HF 1500 KIT
Received Jun 12, 2024 · Event occurred Jun 10, 2024
Report 3010850471-2024-00051 · MDR key 19524817
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 (BIOMED) CONTACTED FRESENIUS TECHNICAL SERVICES AND REPORTED THAT THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM WOULD NOT POWER UP. UPON EVALUATION THE STAGE 1 MOTOR PROTECTION SWITCH (MPS) AND CONNECTED WIRING HARNESS SUSTAINED THERMAL DAMAGE. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. ONE FUSE WAS BLOWN AND SUBSEQUENTLY REPLACED. THERE WERE NO LOCAL POWER GRID ISSUES OR ELECTRICAL STORMS ON OR AROUND THE REPORTED EVENT DATE. THE MPS AND WIRING HARNESS WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM HAS BEEN RETURNED TO SERVICE. THE PARTS WERE DISCARDED AND ARE NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.
Description of Event or Problem
A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) CONTACTED FRESENIUS TECHNICAL SERVICES AND REPORTED THAT THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM WOULD NOT POWER UP. UPON EVALUATION THE STAGE 1 MOTOR PROTECTION SWITCH (MPS) AND CONNECTED WIRING HARNESS SUSTAINED THERMAL DAMAGE. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. ONE FUSE WAS BLOWN AND SUBSEQUENTLY REPLACED. THERE WERE NO LOCAL POWER GRID ISSUES OR ELECTRICAL STORMS ON OR AROUND THE REPORTED EVENT DATE. THE MPS AND WIRING HARNESS WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM HAS BEEN RETURNED TO SERVICE. THE PARTS WERE DISCARDED AND ARE NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.
Additional Manufacturer Narrative
PLANT INVESTIGATION: NO PHOTOGRAPHS OR SAMPLES WERE PROVIDED FOR REVIEW BY THE MANUFACTURER. HOWEVER THE REPORTED EVENT CAN BE CONFIRMED BY MEANS OF THE COMPLAINT INTAKE INFORMATION. THE THERMAL DAMAGE OCCURRED DUE A BAD ELECTRICAL CONNECTION THAT RESULTED IN HIGH CONTACT RESISTANCE AND THERMAL POWER LOSS. AS HIGHER CURRENTS, THE CONCERNED COMPONENTS ARE EXPOSED TO HIGHER TEMPERATURES RESPECTIVELY, RESULTING IN THE FOUND THERMAL DAMAGE. THE REPORTED FAILURE PATTERN IS A KNOWN ISSUE. CORRECTIVE ACTIONS HAVE BEEN DEFINED AND IMPLEMENTED. A NEW CRIMP CONNECTION WAS REDESIGNED. THIS DESIGN WAS RELEASED AFTER THE MANUFACTURE FOR THIS DEVICE. THE ISSUE CAN BE SOLVED, IF NOT ALREADY DONE, BY REPLACING THE WIRING AND THE MOTOR PROTECTION SWITCH IN STAGE 1 AND STAGE 2 TO PREVENT ADDITIONAL FAILURES.