AQUABPLUS, B2, HF 1500 KIT

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 BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM THAT A P-1 FAILURE OCCURRED. "ERROR CODE F¿04¿50¿04 FAILURE: T1 TEST, PUMP P1 DEFECTIVE" WAS RECEIVED. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. THE RO SYSTEM WAS PLACED INTO EMERGENCY MODE STAGE 2. IT WAS INDICATED UPON INITIAL REPORTING THAT THERMAL DECOMPOSITION WAS IDENTIFIED. THE BIOMED CONFIRMED THE REPORTED EVENT DURING FOLLOW-UP AND PROVIDED ADDITIONAL INFORMATION. THERMAL DAMAGE WAS IDENTIFIED ON THE MOTOR PROTECTION SWITCH (MPS). THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THE SYSTEM IS PLUGGED INTO ITS OWN BREAKER. A BLOWN FUSE WAS ALSO IDENTIFIED IN THE EXTERNAL SERVICE DISCONNECT (NOT A FRESENIUS PRODUCT). THE THERMAL OVERLOAD RELAY DID NOT TRIP. THERE WERE NO LOCAL POWER GRID ISSUES NOR ELECTRICAL STORMS IN THE AREA ON OR AROUND THE REPORTED EVENT DATE. THE MPS WAS REPLACED TO RESOLVE THE REPORTED EVENT. THE SYSTEM WAS RETURNED TO SERVICE FOLLOWING REPAIR. NO PARTS ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Description of Event or Problem

A BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM THAT A P-1 FAILURE OCCURRED. "ERROR CODE F¿04¿50¿04 FAILURE: T1 TEST, PUMP P1 DEFECTIVE" WAS RECEIVED. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. THE RO SYSTEM WAS PLACED INTO EMERGENCY MODE STAGE 2. IT WAS INDICATED UPON INITIAL REPORTING THAT THERMAL DECOMPOSITION WAS IDENTIFIED. THE BIOMED CONFIRMED THE REPORTED EVENT DURING FOLLOW-UP AND PROVIDED ADDITIONAL INFORMATION. THERMAL DAMAGE WAS IDENTIFIED ON THE MOTOR PROTECTION SWITCH (MPS). THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THE SYSTEM IS PLUGGED INTO ITS OWN BREAKER. A BLOWN FUSE WAS ALSO IDENTIFIED IN THE EXTERNAL SERVICE DISCONNECT (NOT A FRESENIUS PRODUCT). THE THERMAL OVERLOAD RELAY DID NOT TRIP. THERE WERE NO LOCAL POWER GRID ISSUES NOR ELECTRICAL STORMS IN THE AREA ON OR AROUND THE REPORTED EVENT DATE. THE MPS WAS REPLACED TO RESOLVE THE REPORTED EVENT. THE SYSTEM WAS RETURNED TO SERVICE FOLLOWING REPAIR. NO PARTS ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

PLANT INVESTIGATION: THE MANUFACTURER CONFIRMED THE REPORTED ISSUE WITH THE PROVIDED INTAKE INFORMATION. THE CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE 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. THE CABLE LUGS/WIRING AT THE MOTOR PROTECTION SWITCH OVERHEATED AND BECAME DISCOLORED/DAMAGED FROM THE RELEASED THERMAL ENERGY. A MAINS LINE ALSO COULD HAVE BEEN MISSING (AS A RESULT OF THE BAD ELECTRICAL CONTACT) AND THE THERMAL OVERLOAD SWITCH OR THE MOTOR PROTECTION SWITCH (DEPENDING ON THE OPERATION MODE) WAS LOADED UNBALANCED AND COULD HAVE TRIPPED, RESULTING IN THE INTERRUPTION OF DEVICE OPERATION AND SUBSEQUENT ERROR CODES/T1 TEST FAILURES. A CONTRIBUTING FACTOR FOR A TRIPPING MOTOR PROTECTION SWITCH OR THERMAL OVERLOAD RELAY COULD BE ALSO POWER ISSUES (LINE FLUCTUATIONS/BLOWN FUSE) WHICH DO CAUSE HIGHER CURRENTS. THESE CONSTANT HIGH CURRENTS DO ALSO CAUSE A TRIGGERED MOTOR PROTECTION SWITCH OR THERMAL OVERLOAD RELAY. THIS FAILURE IS A KNOWN ISSUE. CORRECTIVE ACTIONS WERE DEFINED. A NEW DESIGN OF THE MOTOR PROTECTION SWITCH AND ITS WIRING WAS DEVELOPED BUT IS CURRENTLY NOT RELEASED FOR THE US MARKET. THE AFFECTED AQUABPLUS SYSTEM WAS MANUFACTURED BEFORE THE IMPLEMENTATION OF THE CORRECTIVE ACTION IN SERIES PRODUCTION. ACCORDING TO THE INTAKE INFORMATION, THE ISSUE WAS RESOLVED BY REPLACING THE MOTOR PROTECTION SWITCH IN STAGE 1. IT IS RECOMMENDED TO CHECK AND REPLACE THE WIRING AND THE MOTOR PROTECTION SWITCH IN STAGE 1 AND STAGE 2 WITH PARTS TO AVOID ADDITIONAL FAILURES.