AQUABPLUS, B2, HF 1500 KIT

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DAMAGE WAS IDENTIFIED ON THE THERMAL OVERLOAD RELAY OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE REPORTED ISSUE WAS DISCOVERED DURING TROUBLESHOOTING. THE BIOMED INITIALLY CONTACTED FRESENIUS FOR ASSISTANCE WHEN THE MOTOR PROTECTION SWITCH (MPS) TRIPPED DURING THE T1 TEST UPON STARTING THE PUMP P1. ERROR CODE F¿04¿50¿04 WAS RECEIVED WITH THE MESSAGE "FAILURE: T1 TEST, PUMP P1 DEFECTIVE." A BAD FUSE WAS IDENTIFIED IN THE EXTERNAL SERVICE DISCONNECT FOR STAGE 1. EVIDENCE OF ARCING WAS NOTED ON THE THERMAL OVERLOAD RELAY. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME OR FLAME. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. THERE WERE NO LOCAL POWER GRID ISSUES ON THE REPORTED EVENT DATE. THE BLOWN FUSE WAS REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM WAS ABLE TO PASS THE T1 TEST. THE RO SYSTEM WAS RETURNED TO SERVICE.

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER THE REPORTED ISSUE WAS CONFIRMED BASED ON THE PHOTOGRAPH AND INFORMATION PROVIDED UPON INTAKE. THIS IS A KNOWN FAILURE. CORRECTIVE ACTIONS HAVE BEEN DEFINED AND IMPLEMENTED FOR THIS KNOWN FAILURE. THIS IS A KNOWN FAILURE. CORRECTIVE ACTIONS HAVE BEEN DEFINED AND IMPLEMENTED FOR THIS KNOWN FAILURE. THE WIRING WAS REDESIGNED AND RELEASED. IT WAS NOT REPORTED THAT THE DAMAGED PARTS WERE REPLACED. IT IS RECOMMENDED, IF NOT ALREADY DONE, TO REPLACE THE MOTOR PROTECTION SWITCH AND BLACK CONNECTION WIRES AGAINST THE IMPROVED DESIGN IN STAGE 1 AND STAGE 2.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DAMAGE WAS IDENTIFIED ON THE THERMAL OVERLOAD RELAY OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE REPORTED ISSUE WAS DISCOVERED DURING TROUBLESHOOTING. THE BIOMED INITIALLY CONTACTED FRESENIUS FOR ASSISTANCE WHEN THE THE MOTOR PROTECTION SWITCH (MPS) TRIPPED DURING THE T1 TEST UPON STARTING THE PUMP P1. ERROR CODE F¿04¿50¿04 WAS RECEIVED WITH THE MESSAGE "FAILURE: T1 TEST, PUMP P1 DEFECTIVE." A BAD FUSE WAS IDENTIFIED IN THE EXTERNAL SERVICE DISCONNECT FOR STAGE 1. EVIDENCE OF ARCING WAS NOTED ON THE THERMAL OVERLOAD RELAY. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME OR FLAME. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. THERE WERE NO LOCAL POWER GRID ISSUES ON THE REPORTED EVENT DATE. THE BLOWN FUSE WAS REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM WAS ABLE TO PASS THE T1 TEST. THE RO SYSTEM WAS RETURNED TO SERVICE.

Additional Manufacturer Narrative

THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.