AQUABPLUS, B2, HF 2000 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 USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM WAS PLACED INTO HEAT DISINFECTION AFTER CLINIC HOURS AND THE STAGE 1 MOTOR PROTECTION SWITCH (MPS) KEPT TRIPPING. AN ALARM WAS RECEIVED ON THE RO SYSTEM BUT THE SPECIFIC ERROR CODE COULD NOT BE PROVIDED. UPON EVALUATION OF THE SYSTEM THERMAL DECOMPOSITION WAS NOTED ON THE WIRE CONNECTIONS TO THE MPS. THE WIRES WERE BURNT. BURNT PLASTIC WAS FOUND INSIDE THE TERMINALS CAUSING A BAD CONNECTION TO THE SWITCH AND THE SUBSEQUENT TRIPPING. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. NO BLOWN FUSES WERE IDENTIFIED. NO POWER ISSUES OR ELECTRICAL STORMS IN THE AREA OCCURRED ON OR AROUND THE REPORTED EVENT DATE. THE BIOMED STATED THAT REPLACEMENTS WERE ORDERED FOR THE MPS AND CONNECTED CABLES. AT THE TIME OF FOLLOW-UP THE CABLES ARE ON BACKORDER AND HAVE NOT ARRIVED. THE REPLACEMENT MPS HAS ARRIVED BUT THE ORIGINAL MPS WAS TESTED AND FOUND TO BE FUNCTIONAL. THE BIOMED REMOVED THE BURNT PLASTIC FROM THE TERMINALS TO REPAIR THE CONNECTION TO THE SWITCH TO PREVENT FURTHER TRIPPING. THE RO SYSTEM REMAINS IN SERVICE. THE REPLACEMENT CABLES WILL BE INSTALLED UPON ARRIVAL. NO PARTS WERE RETURNED TO THE MANUFACTURER. THERE WAS NO PATIENT INVOLVEMENT NOT PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM WAS PLACED INTO HEAT DISINFECTION AFTER CLINIC HOURS AND THE STAGE 1 MOTOR PROTECTION SWITCH (MPS) KEPT TRIPPING. AN ALARM WAS RECEIVED ON THE RO SYSTEM BUT THE SPECIFIC ERROR CODE COULD NOT BE PROVIDED. UPON EVALUATION OF THE SYSTEM THERMAL DECOMPOSITION WAS NOTED ON THE WIRE CONNECTIONS TO THE MPS. THE WIRES WERE BURNT. BURNT PLASTIC WAS FOUND INSIDE THE TERMINALS CAUSING A BAD CONNECTION TO THE SWITCH AND THE SUBSEQUENT TRIPPING. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. NO BLOWN FUSES WERE IDENTIFIED. NO POWER ISSUES OR ELECTRICAL STORMS IN THE AREA OCCURRED ON OR AROUND THE REPORTED EVENT DATE. THE BIOMED STATED THAT REPLACEMENTS WERE ORDERED FOR THE MPS AND CONNECTED CABLES. AT THE TIME OF FOLLOW-UP THE CABLES ARE ON BACKORDER AND HAVE NOT ARRIVED. THE REPLACEMENT MPS HAS ARRIVED BUT THE ORIGINAL MPS WAS TESTED AND FOUND TO BE FUNCTIONAL. THE BIOMED REMOVED THE BURNT PLASTIC FROM THE TERMINALS TO REPAIR THE CONNECTION TO THE SWITCH TO PREVENT FURTHER TRIPPING. THE RO SYSTEM REMAINS IN SERVICE. THE REPLACEMENT CABLES WILL BE INSTALLED UPON ARRIVAL. NO PARTS WERE RETURNED TO THE MANUFACTURER. THERE WAS NO PATIENT INVOLVEMENT NOT PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE.

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER THE MANUFACTURER CONFIRMED THE REPORTED ISSUE BASED ON THE INFORMATION AND PHOTOGRAPH PROVIDED BY THE CUSTOMER. THE MANUFACTURER DETERMINED THAT THE THERMAL DAMAGE OCCURRED DUE TO HIGH CONTACT RESISTANCE AND THERMAL POWER LOSS AT AS THE RESULT OF POOR ELECTRICAL CONTACT AT THE MOTOR PROTECTION SWITCH. THE HIGH CURRENTS RESULTED IN THERMAL DAMAGE TO THE WIRES AND CABLE LUGS. THIS IS A KNOWN FAILURE. CORRECTIVE ACTIONS HAVE BEEN DEFINED AND IMPLEMENTED. A NEW DESIGN OF THE MOTOR PROTECTION SWITCH AND ITS WIRING HAS BEEN DEVELOPED BUT HAS NOT BEEN RELEASED FOR THE US MARKET. ACCORDING TO THE COMPLAINT INTAKE INFORMATION, NO PART WAS REPLACED. TO SOLVE THE ISSUE, IT IS RECOMMENDED TO REPLACE THE COMPLETE WIRING ATTACHED TO THE MOTOR PROTECTION SWITCH STAGE 1. PREVENTIVELY IT IS ALSO RECOMMENDED TO REPLACE THE MOTOR PROTECTION SWITCH AT STAGE 1.