AQUABPLUS, B2, HF 2500 KIT

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER A PHOTOGRAPH WAS PROVIDED THAT WAS USED BY THE MANUFACTURER TO CONFIRM THE REPORTED ISSUE. THE ISSUE WAS CAUSED BY A BAD ELECTRICAL CONTACT IN THE AQUABPLUSHF (HF) CABINET. DUE TO THE BAD ELECTRICAL CONTACT IN THE HF CABINET THE HEATER IS NOT HEATING WITH ALL THREE ELEMENTS. THEREFORE, THE HEATER TEST H1 FAILED DURING THE T1-TEST BECAUSE THE REQUIRED 2°C DELTA TEMPERATURE ARE NOT REACHED IN THE REQUIRED TIME FRAME. AS RESULT, THE REPORTED ERROR CODE W-04-52-01 T1-TEST, HEATER H1 DEFECTIVE WAS TRIGGERED. AS FOLLOW UP ERROR CODES, THE ERROR CODE W-02-52-03 HEAT DISINFECTION STOPPED AND W-02-52-01 TEMP. NOT REACHED WERE TRIGGERED. THE FAILURE PATTERN IS ALREADY KNOWN. CORRECTIVE ACTIONS WERE DEFINED AND IMPLEMENTED. THE AQUABPLUSHF WAS BUILT IN 2018 BEFORE IMPLEMENTATION OF CORRECTIVE ACTIONS. ACCORDING TO THE INTAKE INFORMATION, THE ISSUE WAS SOLVED BY REPLACING THE WIRING AND THE CONTACTOR(S).

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT ERROR W¿04¿52¿01 WAS RECEIVED ALONG WITH THE MESSAGE "WARNING: HEATER H1 DEFECTIVE" ON THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM DURING THE T1 TEST. SOOT WAS IDENTIFIED ON THE Q3 CONTACTOR. THE VOLTAGE ABOVE AND BELOW THE Q4 CONTACTOR WAS TESTED AND ALL 3 PHASE LEGS WERE 201VAC. IT WAS RECOMMENDED TO THE BIOMED TO MEASURE THE HEATER AMPERAGES AND REPLACE THE CONTACTORS Q3 AND Q4 DUE TO THE FOUND SOOT. DURING INITIAL FOLLOW-UP WITH THE BIOMED IT WAS CONFIRMED THAT THERMAL DECOMPOSITION WAS IDENTIFIED ON THE MOTOR PROTECTION SWITCH AND WIRING. THERE WAS NO OBSERVED SMOKE, SPARK, FLAME, OR ARCING. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. DURING ADDITIONAL FOLLOW-UP WITH THE AREA TECHNICAL OPERATIONS MANAGER (ATOM) IT WAS CONFIRMED THAT THE WIRING HARNESS WAS REPLACED WITH AN AVAILABLE SPARE ALONG WITH THE MOTOR PROTECTION SWITCH TO RESOLVE THE REPORTED ISSUE. NO BLOWN FUSES WERE IDENTIFIED WITHIN THE EXTERNAL SERVICE DISCONNECT. THE HEATER RELAY DID NOT TRIP. THERE WERE NO LOCAL POWER GRID ISSUES OR ELECTRICAL STORMS ON OR AROUND THE REPORTED EVENT DATE. THE RO SYSTEM HAS BEEN RETURNED TO FULL OPERATION.

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 ERROR W¿04¿52¿01 WAS RECEIVED ALONG WITH THE MESSAGE "WARNING: HEATER H1 DEFECTIVE" ON THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM DURING THE T1 TEST. SOOT WAS IDENTIFIED ON THE Q3 CONTACTOR. THE VOLTAGE ABOVE AND BELOW THE Q4 CONTACTOR WAS TESTED AND ALL 3 PHASE LEGS WERE ~201VAC. IT WAS RECOMMENDED TO THE BIOMED TO MEASURE THE HEATER AMPERAGES AND REPLACE THE CONTACTORS Q3 AND Q4 DUE TO THE FOUND SOOT. DURING INITIAL FOLLOW-UP WITH THE BIOMED IT WAS CONFIRMED THAT THERMAL DECOMPOSITION WAS IDENTIFIED ON THE MOTOR PROTECTION SWITCH AND WIRING. THERE WAS NO OBSERVED SMOKE, SPARK, FLAME, OR ARCING. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. DURING ADDITIONAL FOLLOW-UP WITH THE AREA TECHNICAL OPERATIONS MANAGER (ATOM) IT WAS CONFIRMED THAT THE WIRING HARNESS WAS REPLACED WITH AN AVAILABLE SPARE ALONG WITH THE MOTOR PROTECTION SWITCH TO RESOLVE THE REPORTED ISSUE. NO BLOWN FUSES WERE IDENTIFIED WITHIN THE EXTERNAL SERVICE DISCONNECT. THE HEATER RELAY DID NOT TRIP. THERE WERE NO LOCAL POWER GRID ISSUES OR ELECTRICAL STORMS ON OR AROUND THE REPORTED EVENT DATE. THE RO SYSTEM HAS BEEN RETURNED TO FULL OPERATION

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B3 (EVENT DATE), G3 (DATE RECEIVED) 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 ERROR W¿04¿52¿01 WAS RECEIVED ALONG WITH THE MESSAGE "WARNING: HEATER H1 DEFECTIVE" ON THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM DURING THE T1 TEST. SOOT WAS IDENTIFIED ON THE Q3 CONTACTOR. THE VOLTAGE ABOVE AND BELOW THE Q4 CONTACTOR WAS TESTED AND ALL 3 PHASE LEGS WERE 201VAC. IT WAS RECOMMENDED TO THE BIOMED TO MEASURE THE HEATER AMPERAGES AND REPLACE THE CONTACTORS Q3 AND Q4 DUE TO THE FOUND SOOT. DURING INITIAL FOLLOW-UP WITH THE BIOMED IT WAS CONFIRMED THAT THERMAL DECOMPOSITION WAS IDENTIFIED ON THE MOTOR PROTECTION SWITCH AND WIRING. THERE WAS NO OBSERVED SMOKE, SPARK, FLAME, OR ARCING. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. DURING ADDITIONAL FOLLOW-UP WITH THE AREA TECHNICAL OPERATIONS MANAGER (ATOM) IT WAS CONFIRMED THAT THE WIRING HARNESS WAS REPLACED WITH AN AVAILABLE SPARE ALONG WITH THE MOTOR PROTECTION SWITCH TO RESOLVE THE REPORTED ISSUE. NO BLOWN FUSES WERE IDENTIFIED WITHIN THE EXTERNAL SERVICE DISCONNECT. THE HEATER RELAY DID NOT TRIP. THERE WERE NO LOCAL POWER GRID ISSUES OR ELECTRICAL STORMS ON OR AROUND THE REPORTED EVENT DATE. THE RO SYSTEM HAS BEEN RETURNED TO FULL OPERATION.