AQUABPLUS, B2, HF 1500 KIT

Description of Event or Problem

THE BIOMEDICAL TECHNICIAN (BIOMED) FOR A USER FACILITY REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE BIOMED CONFIRMED THE REPORTED EVENT DURING FOLLOW-UP AND PROVIDED ADDITIONAL INFORMATION. THE BIOMED INITIALLY REPORTED THAT THE RO SYSTEM ALARMED DURING THE T1 TEST WITH ERROR CODE ¿F¿04¿51¿04 FAILURE: T1 TEST, PUMP P1S DEFECTIVE¿ AND THE STAGE 2 PUMP WOULD NOT TURN ON. THE BIOMED EXPLAINED THAT A POWER SURGE OCCURRED AT THE FACILITY ON THE PRIOR NIGHT. THERMAL DECOMPOSITION WAS IDENTIFIED UPON EVALUATING THE SYSTEM. THE STAGE 2 MOTOR PROTECTION SWITCH (MPS) AND CONNECTED WIRING WERE BURNT. THERE WAS NO BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING ASSOCIATED WITH THE REPORTED ISSUE. NO BLOWN FUSES WERE IDENTIFIED. THE BIOMED ALSO STATED THAT THE ¿CONTACT¿ HAD TRIPPED. THE MPS AND WIRING WERE REPLACED TO RESOLVE THE REPORTED ISSUE AND THE CONTACT WAS RESET. THE RO SYSTEM WAS RETURNED TO FULL SERVICE FOLLOWING REPAIR. NO PARTS WERE 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: THE COMPLAINT SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER THE REPORTED THERMAL DAMAGE WAS CONFIRMED BY THE MANUFACTURER WITH THE PROVIDED INTAKE INFORMATION. THE MOST LIKELY CAUSE FOR THE FAILURE PATTERN IS A BAD ELECTRICAL CONTACT AT THE MOTOR PROTECTION SWITCH. THE CONTACT RESISTANCE AND PUMP CURRENT INCREASED WHICH LED TO INCREASED THERMAL ENERGY AT THE CONTACTS POINTS RESULTING IN OVERHEATED AND DISCOLORED CABLE LUGS AT THE MOTOR PROTECTION SWITCH. THE MOTOR PROTECTION SWITCH WAS LOADED UNBALANCED AND TRIPPED, TRIGGERING ALARM ERROR F-04-51-04 AND INTERRUPTING DEVICE OPERATION. IT SHOULD ALSO BE NOTED THAT POWER SURGES/FLUCTUATIONS HAVE A CONTRIBUTING FACTOR TO THIS FAILURE PATTERN. THIS FAILURE IS A KNOWN ISSUE. CORRECTIVE ACTIONS WERE DEFINED AND IMPLEMENTED. AN IMPROVEMENT TO THE WIRING DESIGN WAS CREATED AND RELEASED. IT IS RECOMMENDED TO REPLACE THE WIRING AND MOTOR PROTECTION SWITCH IN STAGE 1 AND STAGE 2 TO PREVENT ADDITIONAL FAILURES.

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

THE BIOMEDICAL TECHNICIAN (BIOMED) FOR A USER FACILITY REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE BIOMED CONFIRMED THE REPORTED EVENT DURING FOLLOW-UP AND PROVIDED ADDITIONAL INFORMATION. THE BIOMED INITIALLY REPORTED THAT THE RO SYSTEM ALARMED DURING THE T1 TEST WITH ERROR CODE ¿F¿04¿51¿04 FAILURE: T1 TEST, PUMP P1S DEFECTIVE¿ AND THE STAGE 2 PUMP WOULD NOT TURN ON. THE BIOMED EXPLAINED THAT A POWER SURGE OCCURRED AT THE FACILITY ON THE PRIOR NIGHT. THERMAL DECOMPOSITION WAS IDENTIFIED UPON EVALUATING THE SYSTEM. THE STAGE 2 MOTOR PROTECTION SWITCH (MPS) AND CONNECTED WIRING WERE BURNT. THERE WAS NO BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING ASSOCIATED WITH THE REPORTED ISSUE. NO BLOWN FUSES WERE IDENTIFIED. THE BIOMED ALSO STATED THAT THE ¿CONTACT¿ HAD TRIPPED. THE MPS AND WIRING WERE REPLACED TO RESOLVE THE REPORTED ISSUE AND THE CONTACT WAS RESET. THE RO SYSTEM WAS RETURNED TO FULL SERVICE FOLLOWING REPAIR. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE.