AQUABPLUS, B2, HF 1000 KIT

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. THE FAILURE PATTERN IS KNOWN. CORRECTIVE ACTIONS WERE DEFINED AND IMPLEMENTED. THE DESIGN OF THE CRIMPED CABLE LUG WAS CHANGED. THE AFFECTED DEVICE WAS BUILT BEFORE THE IMPLEMENTION OF THE CAPA AND WAS STILL EQUIPPED WITH THE OLD DESIGN OF THE CRIMPED CABLE LUGS AT TIME OF THE FAILURE. THE THERMAL OVERLOAD SWITCH WAS RESET AND THE WIRING WAS REPLACED WITH THE NEW AVAILABLE DESIGN AT STAGE 1 TO SOLVE THE PROBLEM. IT IS UNKNOWN IF THE COMPLETE WIRING ATTACHED TO THE MOTOR PROTECTION SWITCH (POWER CORD AND CONNECTION CABLE BETWEEN MOTOR PROTECTION SWITCH AND CONTACTOR) WAS REPLACED IN STAGE 1. THE MANUFACTURER THEREFORE RECOMMENDS TO REPLACE THE MOTOR PROTECTION SWITCH AT STAGE 1 AND TO PREVENTIVELY REPLACE THE COMPLETE WIRING ATTACHED TO THE MOTOR PROTECTION SWITCH (POWER CORD AND CONNECTION CABLE BETWEEN MOTOR PROTECTION SWITCH AND CONTACTOR) IN STAGES 1 AND 2 WITH THE NEW AVAILABLE IMPROVED WIRING DESIGN.

Description of Event or Problem

A USER FACILITY AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE MAINS POWER CABLE AND CABLES FROM THE MOTOR PROTECTION SWITCH (MPS) OF AN AQUABPLUS REVERSE OSMOSIS (RO) WERE BURNED. THE MPS WAS LOCATED IN STAGE 1. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THE REPORTED ISSUE WAS DISCOVERED DURING MACHINE EVALUATION. THE BIOMED INITIALLY CONTACTED TECHNICAL SERVICES AFTER ENCOUNTERING A PUMP P1S FAILURE DURING THE T1 TEST IN SUPPLY MODE. ERROR CODE F-04-50-04 WAS RECEIVED. THE ATOM ALSO REPORTED THAT THERE WAS NO POWER TO THE DISPLAY. THE ATOM STATED THE THERMAL OVERLOAD RELAY TRIPPED AND WAS RESET. THERE WERE NO BLOWN FUSES IDENTIFIED IN THE LOCAL POWER SUPPLY. THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. THE ATOM CONFIRMED THERE WERE NO LOCAL POWER GRID ISSUES ON OR AROUND THE REPORTED EVENT DATE. THE CONNECTIONS TO THE MPS WERE RESEATED TO RESOLVE THE INITIALLY REPORTED T1 TEST FAILURE AND DISPLAY ISSUES. A REPLACEMENT MAINS POWER CABLE AND MPS WERE ORDER TO RESOLVE THE REPORTED THERMAL DAMAGE. THE PARTS WILL BE INSTALLED UPON THEIR ARRIVAL. NO SAMPLE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANYONE AS A RESULT OF THE REPORTED ISSUE.

Description of Event or Problem

A USER FACILITY AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE MAINS POWER CABLE AND CABLES FROM THE MOTOR PROTECTION SWITCH (MPS) OF AN AQUABPLUS REVERSE OSMOSIS (RO) WERE BURNED. THE MPS WAS LOCATED IN STAGE 1. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THE REPORTED ISSUE WAS DISCOVERED DURING MACHINE EVALUATION. THE BIOMED INITIALLY CONTACTED TECHNICAL SERVICES AFTER ENCOUNTERING A PUMP P1S FAILURE DURING THE T1 TEST IN SUPPLY MODE. ERROR CODE F-04-50-04 WAS RECEIVED. THE ATOM ALSO REPORTED THAT THERE WAS NO POWER TO THE DISPLAY. THE ATOM STATED THE THERMAL OVERLOAD RELAY TRIPPED AND WAS RESET. THERE WERE NO BLOWN FUSES IDENTIFIED IN THE LOCAL POWER SUPPLY. THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. THE ATOM CONFIRMED THERE WERE NO LOCAL POWER GRID ISSUES ON OR AROUND THE REPORTED EVENT DATE. THE CONNECTIONS TO THE MPS WERE RESEATED TO RESOLVE THE INITIALLY REPORTED T1 TEST FAILURE AND DISPLAY ISSUES. A REPLACEMENT MAINS POWER CABLE AND MPS WERE ORDER TO RESOLVE THE REPORTED THERMAL DAMAGE. THE PARTS WILL BE INSTALLED UPON THEIR ARRIVAL. NO SAMPLE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANYONE AS A RESULT OF THE REPORTED ISSUE.

Additional Manufacturer Narrative

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