AQUABPLUS, B2, HF 2500 KIT

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO SAMPLES WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONALLY, NO PHOTOGRAPHS WERE PROVIDED FOR REVIEW. THE REPORTED ISSUE IS CONFIRMED WITH THE PROVIDED INTAKE INFORMATION. THE THERMAL DAMAGE WAS MOST LIKELY CAUSED FROM LOW CONTACT PRESSURE AT THE CONTACT PINS (BLADE RECEPTACLES) OF THE MOTOR PROTECTION SWITCH WHICH RESULTED IN HIGH CONTACT RESISTANCE RESULTING IN HIGH THERMAL POWER LOSS, NOTED AS THE THERMAL DAMAGE. WITHIN THE INTAKE INFORMATION IT IS MENTIONED THAT STORMS IN THE AREA ARE MOST LIKELY THE REASON FOR THE REPORTED EVENT. STORMS CAN CAUSE LINE FLUCTUATIONS WHERE THE THERMAL OVERLOAD SWITCH IS LOADED UNBALANCED AND TRIPS. BUT IN THIS CASE, THE THERMAL OVERLOAD WAS NOT TRIPPED. HOWEVER, VOLTAGE FLUCTUATIONS DUE TO A STORM CAN FAVOR THE OCCURRENCE OF THERMAL DAMAGE. THIS FAILURE IS A KNOWN ISSUE. CORRECTIVE ACTIONS WERE DEFINED AND IMPLEMENTED. THE DESIGN OF THE CRIMPED CABLE LUG WAS CHANGED. THE AFFECTED DEVICE WAS BUILT BEFORE THE IMPLEMENTATION OF THE CORRECTIVE ACTION AND WAS STILL EQUIPPED WITH THE OLD DESIGN OF THE CRIMPED CABLE LUG AT TIME OF THE FAILURE. THE THERMAL DAMAGE CAN BE SOLVED, IF NOT ALREADY DONE, BY REPLACING THE WIRING AND THE MOTOR PROTECTION SWITCH IN STAGE 1 AND STAGE 2 TO PREVENT ADDITIONAL FAILURES.

Description of Event or Problem

THE BIOMEDICAL TECHNICIAN (BIOMED) FOR A USER FACILITY REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM DISPLAYED ERROR CODE "W¿01¿50¿01 - CD-F SENSOR DEFECTIVE" DURING THE T1 TEST. THE BIOMED STATED DURING FOLLOW-UP THAT THE PRESSURE ON THE PRETREATMENT MONITOR WAS RAISED TO RESOLVE THIS ISSUE. FUNCTIONAL TESTING WAS PERFORMED AND COMPLETED WITHOUT ERROR. THE BIOMED ALSO REPORTED THAT THERMAL DECOMPOSITION WAS IDENTIFIED ON THE WIRES CONNECTED TO THE POWER SWITCH. FURTHER FOLLOW-UP WAS PERFORMED TO OBTAIN ADDITIONAL INFORMATION. THE WIRES ALSO APPEARED TO HAVE NO INSULATION. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. NO ALARMS OR CODES WERE RECEIVED. THE THERMAL OVERLOAD RELAY DID NOT TRIP. THERE WERE NO IDENTIFIED BLOWN FUSES. THE SYSTEM IS PLUGGED INTO ITS OWN BREAKER. THE SUSPECTED CAUSE FOR THIS ISSUE WERE THE WEATHER CONDITIONS IN THE AREA WHERE THE FACILITY IS LOCATED AS STORMS OCCUR OFTEN. REPLACEMENT WIRING WAS ORDERED TO RESOLVE THE THERMAL DAMAGE. THE SYSTEM REMAINS IN SERVICE AND RUNNING WITHOUT FURTHER ISSUE UNTIL THE REPLACEMENT WIRING IS RECEIVED AND INSTALLED. NO PARTS WERE REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION.

Description of Event or Problem

THE BIOMEDICAL TECHNICIAN (BIOMED) FOR A USER FACILITY REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM DISPLAYED ERROR CODE "W¿01¿50¿01 - CD-F SENSOR DEFECTIVE" DURING THE T1 TEST. THE BIOMED STATED DURING FOLLOW-UP THAT THE PRESSURE ON THE PRETREATMENT MONITOR WAS RAISED TO RESOLVE THIS ISSUE. FUNCTIONAL TESTING WAS PERFORMED AND COMPLETED WITHOUT ERROR. THE BIOMED ALSO REPORTED THAT THERMAL DECOMPOSITION WAS IDENTIFIED ON THE WIRES CONNECTED TO THE POWER SWITCH. FURTHER FOLLOW-UP WAS PERFORMED TO OBTAIN ADDITIONAL INFORMATION. THE WIRES ALSO APPEARED TO HAVE NO INSULATION. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. NO ALARMS OR CODES WERE RECEIVED. THE THERMAL OVERLOAD RELAY DID NOT TRIP. THERE WERE NO IDENTIFIED BLOWN FUSES. THE SYSTEM IS PLUGGED INTO ITS OWN BREAKER. THE SUSPECTED CAUSE FOR THIS ISSUE WERE THE WEATHER CONDITIONS IN THE AREA WHERE THE FACILITY IS LOCATED AS STORMS OCCUR OFTEN. REPLACEMENT WIRING WAS ORDERED TO RESOLVE THE THERMAL DAMAGE. THE SYSTEM REMAINS IN SERVICE AND RUNNING WITHOUT FURTHER ISSUE UNTIL THE REPLACEMENT WIRING IS RECEIVED AND INSTALLED. NO PARTS WERE REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION.

Additional Manufacturer Narrative

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