AQUABPLUS, B2, HF 2000 KIT

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 BY THE CUSTOMER. THE FAILURE CAUSE CAN BE ATTRIBUTED TO A BAD ELECTRICAL CONTACT 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 FOUND THERMAL DAMAGE. THE FAILURE PATTERN IS A KNOWN ISSUE. CORRECTIVE ACTIONS WERE DEFINED AND IMPLEMENTED. THE CRIMPED CABLE LUG WAS REDESIGNED AND RELEASED. THE CONCERNED AQUABPLUS DEVICE (B)(6) WAS MANUFACTURED PRIOR TO REDESIGN OF THE CABLE LUG. ACCORDING TO 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 USED PARTS ARE MATCHING THE NEW AVAILABLE DESIGN AND TO UPGRADE THE COMPLETE WIRING OF THE MOTOR PROTECTION SWITCH AT STAGE 2 WITH THE NEW AVAILABLE WIRING DESIGN.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS THAT THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. ERROR F-01-52-03 WAS RECEIVED ALONG WITH THE MESSAGE "PUMP P5 FAILURE." THE H-F WAS DISABLED IN ORDER TO PASS THE T-1 TEST AND RUN THE SYSTEM IN SUPPLY MODE. THE CUSTOMER WAS ADVISED TO MEASURE THE CONTINUITY OF THE FUSES OF THE H-F AND REPLACE FUSES AS NECESSARY. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THERMAL DECOMPOSITION WAS IDENTIFIED ON THE STAGE 1 POWER SWITCH AND WIRING. THERE WAS NO OBSERVED SMOKE, SPARK, FLAME, OR ARCING HOWEVER A BURNING SMELL WAS NOTED. THERE WERE NO POWER ISSUES OR ELECTRICAL STORMS IN THE AREA ON OR AROUND THE REPORTED EVENT DATE. BOTH THE SWITCH AND THE WIRING WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE SYSTEM HAS BEEN RETURNED TO SERVICE. NO PARTS ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. PHOTOGRAPHS WERE OBTAINED FOR REVIEW, SEE ATTACHED. THE ISSUE WAS IDENTIFIED UPON MACHINE EVALUATION WHEN THE PUMP TRIPPED DURING HEAT DISINFECTION. THE BREAKER FROM THE H-F (THAT CONTROLS THE PUMP) TRIPPED AND REQUIRED RESET. TWO BLOWN FUSES WERE ALSO IDENTIFIED IN THE EXTERNAL SERVICE DISCONNECT AND REPLACED. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS 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.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS THAT THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. ERROR F-01-52-03 WAS RECEIVED ALONG WITH THE MESSAGE "PUMP P5 FAILURE." THE H-F WAS DISABLED IN ORDER TO PASS THE T-1 TEST AND RUN THE SYSTEM IN SUPPLY MODE. THE CUSTOMER WAS ADVISED TO MEASURE THE CONTINUITY OF THE FUSES OF THE H-F AND REPLACE FUSES AS NECESSARY. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THERMAL DECOMPOSITION WAS IDENTIFIED ON THE STAGE 1 POWER SWITCH AND WIRING. THERE WAS NO OBSERVED SMOKE, SPARK, FLAME, OR ARCING HOWEVER A BURNING SMELL WAS NOTED. THERE WERE NO POWER ISSUES OR ELECTRICAL STORMS IN THE AREA ON OR AROUND THE REPORTED EVENT DATE. BOTH THE SWITCH AND THE WIRING WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE SYSTEM HAS BEEN RETURNED TO SERVICE. NO PARTS ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. PHOTOGRAPHS WERE OBTAINED FOR REVIEW, SEE ATTACHED. THE ISSUE WAS IDENTIFIED UPON MACHINE EVALUATION WHEN THE PUMP TRIPPED DURING HEAT DISINFECTION. THE BREAKER FROM THE H-F (THAT CONTROLS THE PUMP) TRIPPED AND REQUIRED RESET. TWO BLOWN FUSES WERE ALSO IDENTIFIED IN THE EXTERNAL SERVICE DISCONNECT AND REPLACED. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE.