AQUABPLUS, B2, HF 2000 KIT

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER PHOTOGRAPHS WERE PROVIDED FOR REVIEW. THERMAL DAMAGE WAS IDENTIFIED AT THE CONTACTOR Q2, WIRING, AND FUSE F3, WHICH WAS MOST LIKELY CAUSED BY A LOOSENED SCREW CONNECTION THAT OCCURRED DURING SHIPMENT. MOST LIKELY IT WAS NOT TIGHTENED DURING OPERATIONAL QUALIFICATION AND SERVICING, RESULTING IN INCREASED THERMAL ENERGY AND HEAT EMISSION THAT DAMAGED THE HOUSING PARTS OF CONTACTOR Q2 AND CIRCUIT BREAKER F3. THIS IS A KNOWN ISSUE. THE MANUFACTURER RECOMMENDS REPLACEMENT OF THE WIRING, CONTACTOR Q2 AND FUSE F3 IF NOT ALREADY DONE. REVIEW OF A DEVICE HISTORY RECORD FOR THIS CASE IS NOT REQUIRED.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT SEVERE THERMAL DAMAGE WAS IDENTIFIED WITHIN THE HF PORTION OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE BIOMED STATED THE REPORTED ISSUE WAS FOUND DURING MACHINE REPAIR. THE BIOMED WAS INITIALLY CONTACTED WHEN THE RO SYSTEM WOULD NOT COMPLETE HEAT DISINFECTION. THE RO SYSTEM NORMALLY COMPLETES HEAT DISINFECTION OUTSIDE OF CLINIC HOURS EVERY SUNDAY MORNING. THE BIOMED CONFIRMED THAT ERROR W¿04¿52¿01 WAS RECEIVED ALONG WITH THE MESSAGE "WARNING: T1 TEST, HEATER H1 DEFECTIVE." MELTED WIRES WERE IDENTIFIED ON CONTACTOR Q2 AND F3. IT WAS REPORTED THAT NO DAMAGE WAS IDENTIFIED ON THE HEATERS. THERE WAS NO OBSERVED SMOKE, SPARK, FLAME, OR ARCING WAS OBSERVED. A BURNING SMELL WAS NOTED .ALL THE FUSES WERE FOUND TO BE BLOWN. THE AREA TECHNICAL OPERATIONS MANAGER (ATOM) AND REGIONAL TECHNICAL OPERATIONS MANAGER (RTOM) WERE NOTIFIED OF THE REPORTED EVENT. PER THE ADVICE OF TECHNICAL SERVICES THE MAIN BREAKER TO THE HEATER WAS SHUT OFF. THE BIOMED WAS ADVISED TO COMPLETE A CHEMICAL DISINFECTION EVERY OTHER WEEK IN THE ABSENCE OF PERFORMING A HEAT DISINFECTION. THE RO SYSTEM REMAINS IN SERVICE PENDING REPAIR. AT THE TIME OF FOLLOW-UP, A PURCHASE ORDER (PO) HAD BEEN APPROVED FOR THE ONSITE EVALUATION OF THE SYSTEM BY A FRESENIUS TECHNICIAN. THE MACHINE RESOLUTION IS PENDING THE RESULT OF THE EVALUATION. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. ADDITIONAL FOLLOW-UP WAS PERFORMED WITH THE BIOMED. THE AREA TECHNICAL OPERATION MANAGER (ATOM) AND REGIONAL TECHNICAL OPERATION MANAGER (RTOM) FOR THE CLINIC WENT ONSITE 5/28/2024 TO DETERMINE THE RESOLUTION FOR THIS MACHINE. PER THE ATOM AND RTOM IT WAS DETERMINED THAT A 10-GAUGE WIRE FROM THE 60- AMP RELAY CAME LOOSE, ARCED, MELTED THROUGH THE SIDE OF THE RELAY, MELTING THE FUSE BLOCK LOCATED NEXT TO IT. NO FACILITY SMOKE DETECTORS WERE TRIGGERED AND A FIRE EXTINGUISHER WAS NOT REQUIRED TO ADDRESS THE ISSUE. THE REPORTED ISSUE OCCURRED OUTSIDE OF CLINIC HOURS WHEN NO ONE WAS PRESENT AT THE FACILITY. IT WAS CLARIFIED THAT ALL FUSE BLOCKS BLEW. IT WAS CONFIRMED THE H-F UNIT IS ORIGINAL AND WAS INSTALLED IN 2015. REGULAR MAINTENANCE IS PERFORMED TO THE SYSTEM AS RECOMMENDED. ANNUAL MAINTENANCE IS DUE IN JUNE 2024. TO RESOLVE THIS ISSUE, WIRES FROM ANOTHER H-F UNIT WILL BE INSTALLED, ALONG WITH A REPLACEMENT RELAY AND REPLACEMENT FUSE BLOCK. AT THIS TIME, THE SYSTEM REMAINS PENDING REPAIR.

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 SEVERE THERMAL DAMAGE WAS IDENTIFIED WITHIN THE HF PORTION OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE BIOMED STATED THE REPORTED ISSUE WAS FOUND DURING MACHINE REPAIR. THE BIOMED WAS INITIALLY CONTACTED WHEN THE RO SYSTEM WOULD NOT COMPLETE HEAT DISINFECTION. THE RO SYSTEM NORMALLY COMPLETES HEAT DISINFECTION OUTSIDE OF CLINIC HOURS EVERY SUNDAY MORNING. THE BIOMED CONFIRMED THAT ERROR W¿04¿52¿01 WAS RECEIVED ALONG WITH THE MESSAGE "WARNING: T1 TEST, HEATER H1 DEFECTIVE." MELTED WIRES WERE IDENTIFIED ON CONTACTOR Q2 AND F3. IT WAS REPORTED THAT NO DAMAGE WAS IDENTIFIED ON THE HEATERS. THERE WAS NO OBSERVED SMOKE, SPARK, FLAME, OR ARCING WAS OBSERVED. A BURNING SMELL WAS NOTED .ALL THE FUSES WERE FOUND TO BE BLOWN. THE AREA TECHNICAL OPERATIONS MANAGER (ATOM) AND REGIONAL TECHNICAL OPERATIONS MANAGER (RTOM) WERE NOTIFIED OF THE REPORTED EVENT. PER THE ADVICE OF TECHNICAL SERVICES THE MAIN BREAKER TO THE HEATER WAS SHUT OFF. THE BIOMED WAS ADVISED TO COMPLETE A CHEMICAL DISINFECTION EVERY OTHER WEEK IN THE ABSENCE OF PERFORMING A HEAT DISINFECTION. THE RO SYSTEM REMAINS IN SERVICE PENDING REPAIR. AT THE TIME OF FOLLOW-UP, A PURCHASE ORDER (PO) HAD BEEN APPROVED FOR THE ONSITE EVALUATION OF THE SYSTEM BY A FRESENIUS TECHNICIAN. THE MACHINE RESOLUTION IS PENDING THE RESULT OF THE EVALUATION. THERE WAS NO PATIENT INVOLVEMENT NOR 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 SEVERE THERMAL DAMAGE WAS IDENTIFIED WITHIN THE HF PORTION OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE BIOMED STATED THE REPORTED ISSUE WAS FOUND DURING MACHINE REPAIR. THE BIOMED WAS INITIALLY CONTACTED WHEN THE RO SYSTEM WOULD NOT COMPLETE HEAT DISINFECTION. THE RO SYSTEM NORMALLY COMPLETES HEAT DISINFECTION OUTSIDE OF CLINIC HOURS EVERY SUNDAY MORNING. THE BIOMED CONFIRMED THAT ERROR W¿04¿52¿01 WAS RECEIVED ALONG WITH THE MESSAGE "WARNING: T1 TEST, HEATER H1 DEFECTIVE." MELTED WIRES WERE IDENTIFIED ON CONTACTOR Q2 AND F3. IT WAS REPORTED THAT NO DAMAGE WAS IDENTIFIED ON THE HEATERS. THERE WAS NO OBSERVED SMOKE, SPARK, FLAME, OR ARCING WAS OBSERVED. A BURNING SMELL WAS NOTED .ALL THE FUSES WERE FOUND TO BE BLOWN. THE AREA TECHNICAL OPERATIONS MANAGER (ATOM) AND REGIONAL TECHNICAL OPERATIONS MANAGER (RTOM) WERE NOTIFIED OF THE REPORTED EVENT. PER THE ADVICE OF TECHNICAL SERVICES THE MAIN BREAKER TO THE HEATER WAS SHUT OFF. THE BIOMED WAS ADVISED TO COMPLETE A CHEMICAL DISINFECTION EVERY OTHER WEEK IN THE ABSENCE OF PERFORMING A HEAT DISINFECTION. THE RO SYSTEM REMAINS IN SERVICE PENDING REPAIR. AT THE TIME OF FOLLOW-UP, A PURCHASE ORDER (PO) HAD BEEN APPROVED FOR THE ONSITE EVALUATION OF THE SYSTEM BY A FRESENIUS TECHNICIAN. THE MACHINE RESOLUTION IS PENDING THE RESULT OF THE EVALUATION. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. ADDITIONAL FOLLOW-UP WAS PERFORMED WITH THE BIOMED. THE AREA TECHNICAL OPERATION MANAGER (ATOM) AND REGIONAL TECHNICAL OPERATION MANAGER (RTOM) FOR THE CLINIC WENT ONSITE (B)(6) 2024 TO DETERMINE THE RESOLUTION FOR THIS MACHINE. PER THE ATOM AND RTOM IT WAS DETERMINED THAT A 10-GAUGE WIRE FROM THE 60- AMP RELAY CAME LOOSE, ARCED, MELTED THROUGH THE SIDE OF THE RELAY, MELTING THE FUSE BLOCK LOCATED NEXT TO IT. NO FACILITY SMOKE DETECTORS WERE TRIGGERED AND A FIRE EXTINGUISHER WAS NOT REQUIRED TO ADDRESS THE ISSUE. THE REPORTED ISSUE OCCURRED OUTSIDE OF CLINIC HOURS WHEN NO ONE WAS PRESENT AT THE FACILITY. IT WAS CLARIFIED THAT ALL FUSE BLOCKS BLEW. IT WAS CONFIRMED THE H-F UNIT IS ORIGINAL AND WAS INSTALLED IN 2015. REGULAR MAINTENANCE IS PERFORMED TO THE SYSTEM AS RECOMMENDED. ANNUAL MAINTENANCE IS DUE IN JUNE 2024. TO RESOLVE THIS ISSUE, WIRES FROM ANOTHER H-F UNIT WILL BE INSTALLED, ALONG WITH A REPLACEMENT RELAY AND REPLACEMENT FUSE BLOCK. AT THIS TIME, THE SYSTEM REMAINS PENDING REPAIR.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5 (EVENT DESCRIPTION), H6 (MEDICAL DEVICE PROBLEM CODE) THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5 (EVENT DESCRIPTION), H10 (PLANT INVESTIGATION) PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE REPORTED EVENT WAS MOST LIKELY CAUSED BY BAD ELECTRICAL CONTACTING AT CONTACTOR Q2 AND CIRCUIT BREAKER F3 IN THE ELECTRICAL CABINET OF THE AQUABPLUS HF. DUE TO THE BAD ELECTRICAL CONTACTING, THE THERMAL ENERGY AND HEAT EMISSION WERE INCREASED, RESULTING IN THE IDENTIFIED THERMAL DAMAGE AT CONTACTOR Q2 AND CIRCUIT BREAKER F3 IN THE ELECTRICAL CABINET OF THE AQUABPLUS HF. THE BAD ELECTRICAL CONTACT/S WERE MOST LIKELY CAUSED BY LOOSENED SCREW CONNECTIONS DURING SHIPMENT. THIS FAILURE PATTERN IS KNOWN. CORRECTIVE ACTIONS WERE DEFINED AND IMPLEMENTED IN JANUARY 2020. THE SERVICE MANUAL WAS UPDATED WITH INFORMATION ABOUT THE REQUIRED TIGHTENING TORQUES FOR THE SCREW TERMINAL CONNECTIONS, WHICH NEED TO BE TIGHTENED DURING OPERATIONAL QUALIFICATION. THE CONCERNED DEVICE WAS MANUFACTURED IN 2015, BEFORE THE CORRECTIVE ACTIONS OF CAPA WERE IMPLEMENTED. ACCORDING THE AVAILABLE INFORMATION, CONTACTOR Q2 AND CIRCUIT BREAKER F3 WERE REPLACED TO SOLVE THE ISSUE. IT IS RECOMMENDED TO CHECK THE TIGHTENING TORQUES OF ALL SCREW TERMINAL CONNECTIONS.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT SEVERE THERMAL DAMAGE WAS IDENTIFIED WITHIN THE HF PORTION OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE BIOMED STATED THE REPORTED ISSUE WAS FOUND DURING MACHINE REPAIR. THE BIOMED WAS INITIALLY CONTACTED WHEN THE RO SYSTEM WOULD NOT COMPLETE HEAT DISINFECTION. THE RO SYSTEM NORMALLY COMPLETES HEAT DISINFECTION OUTSIDE OF CLINIC HOURS EVERY SUNDAY MORNING. THE BIOMED CONFIRMED THAT ERROR W¿04¿52¿01 WAS RECEIVED ALONG WITH THE MESSAGE "WARNING: T1 TEST, HEATER H1 DEFECTIVE." MELTED WIRES WERE IDENTIFIED ON CONTACTOR Q2 AND F3. IT WAS REPORTED THAT NO DAMAGE WAS IDENTIFIED ON THE HEATERS. THERE WAS NO OBSERVED SMOKE, SPARK, FLAME, OR ARCING WAS OBSERVED. A BURNING SMELL WAS NOTED .ALL THE FUSES WERE FOUND TO BE BLOWN. THE AREA TECHNICAL OPERATIONS MANAGER (ATOM) AND REGIONAL TECHNICAL OPERATIONS MANAGER (RTOM) WERE NOTIFIED OF THE REPORTED EVENT. PER THE ADVICE OF TECHNICAL SERVICES THE MAIN BREAKER TO THE HEATER WAS SHUT OFF. THE BIOMED WAS ADVISED TO COMPLETE A CHEMICAL DISINFECTION EVERY OTHER WEEK IN THE ABSENCE OF PERFORMING A HEAT DISINFECTION. THE RO SYSTEM REMAINS IN SERVICE PENDING REPAIR. AT THE TIME OF FOLLOW-UP, A PURCHASE ORDER (PO) HAD BEEN APPROVED FOR THE ONSITE EVALUATION OF THE SYSTEM BY A FRESENIUS TECHNICIAN. THE MACHINE RESOLUTION IS PENDING THE RESULT OF THE EVALUATION. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. ADDITIONAL FOLLOW-UP WAS PERFORMED WITH THE BIOMED. THE AREA TECHNICAL OPERATION MANAGER (ATOM) AND REGIONAL TECHNICAL OPERATION MANAGER (RTOM) FOR THE CLINIC WENT ONSITE (B)(6) 2024 TO DETERMINE THE RESOLUTION FOR THIS MACHINE. PER THE ATOM AND RTOM IT WAS DETERMINED THAT A 10-GAUGE WIRE FROM THE 60- AMP RELAY CAME LOOSE, ARCED, MELTED THROUGH THE SIDE OF THE RELAY, MELTING THE FUSE BLOCK LOCATED NEXT TO IT. NO FACILITY SMOKE DETECTORS WERE TRIGGERED AND A FIRE EXTINGUISHER WAS NOT REQUIRED TO ADDRESS THE ISSUE. THE REPORTED ISSUE OCCURRED OUTSIDE OF CLINIC HOURS WHEN NO ONE WAS PRESENT AT THE FACILITY. IT WAS CLARIFIED THAT ALL FUSE BLOCKS BLEW. IT WAS CONFIRMED THE H-F UNIT IS ORIGINAL AND WAS INSTALLED IN 2015. REGULAR MAINTENANCE IS PERFORMED TO THE SYSTEM AS RECOMMENDED. ANNUAL MAINTENANCE IS DUE IN JUNE 2024. TO RESOLVE THIS ISSUE, WIRES FROM ANOTHER H-F UNIT WILL BE INSTALLED, ALONG WITH A REPLACEMENT RELAY AND REPLACEMENT FUSE BLOCK. AT THIS TIME, THE SYSTEM REMAINS PENDING REPAIR. ADDITIONAL INFORMATION WAS PROVIDED DURING FURTHER FOLLOW-UP. TO RESOLVE THIS ISSUE, WIRES FROM ANOTHER H-F UNIT WERE INSTALLED, ALONG WITH A REPLACEMENT RELAY AND REPLACEMENT FUSE BLOCK. THE RO SYSTEM WAS RETURNED TO FULL OPERATION FOLLOWING REPAIR. NO PARTS ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.