AQUABPLUS, B2, HF 2500 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

IT WAS REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM RECEIVED ERROR F-04-50-04 ALONG WITH THE MESSAGE "FAILURE T1 TEST, PUMP P1 DEFECTIVE MESSAGE" DURING THE T1 TEST. THERMAL DECOMPOSITION WAS IDENTIFIED TO THE STAGE 1 MOTOR PROTECTION SWITCH (MPS), POWER CORD, AND CONNECTED WIRING UPON EVALUATION OF THE RO SYSTEM. THE THERMAL OVERLOAD RELAY WAS ALSO TRIPPED. THE THERMAL OVERLOAD RELAY WAS RESET. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. THERE WERE NO BLOWN FUSES LOCATED WITHIN THE EXTERNAL SERVICE DISCONNECT. THERE WERE NO LOCAL POWER GRID ISSUES OR ELECTRICAL STORMS IN THE AREA ON OR AROUND THE REPORTED EVENT DATE. THE MPS, POWER CORD, AND CONNECTED WIRING WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM WAS RETURNED TO FULL OPERATION. NO SAMPLES ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER A PHOTOGRAPH WAS PROVIDED AND USED ALONG WITH THE CASE DETAILS TO CONFIRM THE REPORTED ISSUE. THE MOST LIKELY FAILURE CAUSE FOR THE THERMAL DAMAGE CAN BE ATTRIBUTED TO POOR ELECTRICAL CONTACTING BETWEEN THE CRIMP CONNECTOR/S AND THE CONTACT PIN/S AT THE MOTOR PROTECTION SWITCH AT STAGE 1. THE THERMAL DAMAGE OCCURRED DUE TO HIGH CONTACT RESISTANCE AND THERMAL POWER LOSS AT THE BAD CONTACTING CONNECTIONS. AS HIGHER CURRENTS OCCUR, THE WIRES AND CABLE LUGS ARE EXPOSED TO HIGHER TEMPERATURES RESPECTIVELY, RESULTING IN THE IDENTIFIED THERMAL DAMAGE. THIS ISSUE IS A KNOWN FAILURE. CORRECTIVE ACTIONS HAVE BEEN DEFINED AND IMPLEMENTED. THE CRIMPED CABLE LUG HAS BEEN REDESIGNED. THIS DESIGN CHANGE WAS RELEASED. ACCORDING THE AVAILABLE INFORMATION, THE PROBLEM WAS SOLVED BY REPLACING THE MOTOR PROTECTION SWITCH STAGE 1 AND ITS CONNECTED WIRING. IT IS RECOMMENDED TO CHECK IF THE REPLACEMENT PARTS ARE CONSISTENT WITH THE NEW AVAILABLE DESIGN.

Description of Event or Problem

IT WAS REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM RECEIVED ERROR F-04-50-04 ALONG WITH THE MESSAGE "FAILURE T1 TEST, PUMP P1 DEFECTIVE MESSAGE" DURING THE T1 TEST. THERMAL DECOMPOSITION WAS IDENTIFIED TO THE STAGE 1 MOTOR PROTECTION SWITCH (MPS), POWER CORD, AND CONNECTED WIRING UPON EVALUATION OF THE RO SYSTEM. THE THERMAL OVERLOAD RELAY WAS ALSO TRIPPED. THE THERMAL OVERLOAD RELAY WAS RESET. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. THERE WERE NO BLOWN FUSES LOCATED WITHIN THE EXTERNAL SERVICE DISCONNECT. THERE WERE NO LOCAL POWER GRID ISSUES OR ELECTRICAL STORMS IN THE AREA ON OR AROUND THE REPORTED EVENT DATE. THE MPS, POWER CORD, AND CONNECTED WIRING WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM WAS RETURNED TO FULL OPERATION. NO SAMPLES ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.