AQUABPLUS, B2, HF 1500 KIT

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNCIAL SERVICES THAT THERE WAS NO POWER TO THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE BIOMED STATED THAT THE REPORTED EVENT WAS IDENTIFIED OUTSIDE OF CLINIC HOURS. THE CLINIC IS NOT OPEN ON MONDAYS BUT THE BIOMED CAME ONSITE TO COMPLETE WORK AND THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM WOULD NOT POWER ON. UPON EVALUATION THE BIOMED IDENTIFIED A BURNT WIRE CONNECTION IN STAGE 1 BETWEEN THE 24V POWER SUPPLY AND THE MOTHERBOARD. PER RECOMMENDATION FROM FRESENIUS TECHNICAL SERVICES, THE POWER SUPPLY AND CABLE FROM STAGE 2 WERE TRANSFERRED TO STAGE 1. THE BIOMED STATED THAT UPON INSTALLING THE PARTS INTO STAGE 1 AND POWERING ON THE MACHINE THAT SMOKE AND A BURNING SMELL WERE OBSERVED. THE RO SYSTEM WAS POWERED DOWN TO EXTINGUISH THE SMOKE. USE OF A FIRE EXTINGUISHER WAS NOT REQUIRED AND THE SMOKE DID NOT TRIGGER ANY SMOKE DETECTORS WITHIN THE FACILITY. THE BIOMED REPLACED THE POWER SUPPLY BOARD IN BOTH STAGES AS WELL AS THE STAGE 1 WIRE CONNECTION TO THE MOTHERBOARD TO RESOLVE THE REPORTED THERMAL DAMAGE. THE BIOMED CONFIRMED THAT NO THERMAL DAMAGE WAS IDENTIFIED ON THE MOTHERBOARD. THE RO SYSTEM WAS RETURNED TO FULL OPERATION FOLLOWING REPAIR. THERE WAS NO PATIENT INVOLVEMENT NOR HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. A PHOTOGRAPH WAS REPORTED TO BE AVAILABLE FOR REVIEW BY THE MANUFACTURER. SAMPLES WERE OBTAINED BY FRESENIUS FOR PHYSICAL EVALUATION BY THE MANUFACTURER.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D3 PLANT INVESTIGATION: A SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER, THE REPORTED THERMAL DECOMPOSITION WAS CONFIRMED USING THE PROVIDED PHOTOGRAPHS AND COMPLAINT INTAKE INFORMATION. THE CAUSE OF THE REPORTED ISSUE IS DETERMINED TO BE BAD ELECTRICAL CONTACTING. A BAD ELECTRICAL CONTACT AT A PIN OF THE 24 VDC CONNECTOR RESULTS IN HIGH TRANSITION RESISTANCE AND HIGH THERMAL ENERGY WHICH CAUSED THE REPORTED THERMAL DAMAGE ON THE CONNECTOR. THIS IS A KNOWN FAILURE. CORRECTIVE ACTIONS WERE DEFINED AND IMPLEMENTED. THE MANUFACTURING PROCESS OF THE 24 VDC CABLE/CONNECTOR WAS IMPROVED. THE PRODUCTION IMPROVEMENT WAS IMPLEMENTED IN APRIL 2023. THE CONCERNED DEVICE 9BPS2397 WAS MANUFACTURED IN 2019, BEFORE THE CHANGE OF THE MANUFACTURING PROCESS OF THE 24 VDC CABLE/CONNECTOR. ACCORDING THE AVAILABLE INFORMATION, THE 24 VDC CABLE/CONNECTOR WAS REPLACED TO SOLVE THE ISSUE. IF NOT ALREADY DONE, IT IS RECOMMENDED TO ALSO REPLACE THE 24 VDC CABLE/CONNECTOR IN STAGE 2.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNCIAL SERVICES THAT THERE WAS NO POWER TO THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE BIOMED STATED THAT THE REPORTED EVENT WAS IDENTIFIED OUTSIDE OF CLINIC HOURS. THE CLINIC IS NOT OPEN ON MONDAYS BUT THE BIOMED CAME ONSITE TO COMPLETE WORK AND THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM WOULD NOT POWER ON. UPON EVALUATION THE BIOMED IDENTIFIED A BURNT WIRE CONNECTION IN STAGE 1 BETWEEN THE 24V POWER SUPPLY AND THE MOTHERBOARD. PER RECOMMENDATION FROM FRESENIUS TECHNICAL SERVICES, THE POWER SUPPLY AND CABLE FROM STAGE 2 WERE TRANSFERRED TO STAGE 1. THE BIOMED STATED THAT UPON INSTALLING THE PARTS INTO STAGE 1 AND POWERING ON THE MACHINE THAT SMOKE AND A BURNING SMELL WERE OBSERVED. THE RO SYSTEM WAS POWERED DOWN TO EXTINGUISH THE SMOKE. USE OF A FIRE EXTINGUISHER WAS NOT REQUIRED AND THE SMOKE DID NOT TRIGGER ANY SMOKE DETECTORS WITHIN THE FACILITY. THE USER FACILITY REQUESTED ONSITE SERVICE FROM A FRESENIUS FIELD SERVICE TECHNICIAN (FST). THE FST CONFIRMED THE REPORTED THERMAL DAMAGE ON THE POWER UNIT BETWEEN THE 24V CONNECTION TO THE MOTHERBOARD. THE FST REMOVED THE POWER SUPPLY AND CONNECTING CABLE FROM STAGE 2 AND INSTALLED THESE COMPONENTS IN STAGE 1. UPON POWERING UP THE RO SYSTEM, THE SECOND POWER SUPPLY FAILED. THE FST REPLACED THE POWER SUPPLY UNITS FOR BOTH STAGES, THE CABLE CONNECTION BETWEEN THE POWER SUPPLY AND MOTHERBOARD, THE MOTHERBOARD, THE FAILSAFE BOARD, AND THE CONNECTING BOARD. THE FST ALSO REPOSITIONED THE BUS TERMINAL JUMPER OF B2 FROM WHERE IT WAS DISCOVERED TO BE IN THE INCORRECT POSITION OF 9B/10B TO THE CORRECT POSITION OF 10B/11B. THE RO SYSTEM WAS RETURNED TO FULL OPERATION FOLLOWING REPAIR. THERE WAS NO PATIENT INVOLVEMENT NOR HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. A PHOTOGRAPH WAS REPORTED TO BE AVAILABLE FOR REVIEW BY THE MANUFACTURER. SAMPLES WERE OBTAINED BY FRESENIUS FOR PHYSICAL EVALUATION BY THE MANUFACTURER.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERE WAS NO POWER TO THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE BIOMED STATED THAT THE REPORTED EVENT WAS IDENTIFIED OUTSIDE OF CLINIC HOURS. THE CLINIC IS NOT OPEN ON MONDAYS BUT THE BIOMED CAME ONSITE TO COMPLETE WORK AND THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM WOULD NOT POWER ON. UPON EVALUATION THE BIOMED IDENTIFIED A BURNT WIRE CONNECTION IN STAGE 1 BETWEEN THE 24V POWER SUPPLY AND THE MOTHERBOARD. PER RECOMMENDATION FROM FRESENIUS TECHNICAL SERVICES, THE POWER SUPPLY AND CABLE FROM STAGE 2 WERE TRANSFERRED TO STAGE 1. THE BIOMED STATED THAT UPON INSTALLING THE PARTS INTO STAGE 1 AND POWERING ON THE MACHINE THAT SMOKE AND A BURNING SMELL WERE OBSERVED. THE RO SYSTEM WAS POWERED DOWN TO EXTINGUISH THE SMOKE. USE OF A FIRE EXTINGUISHER WAS NOT REQUIRED AND THE SMOKE DID NOT TRIGGER ANY SMOKE DETECTORS WITHIN THE FACILITY. THE USER FACILITY REQUESTED ONSITE SERVICE FROM A FRESENIUS FIELD SERVICE TECHNICIAN (FST). THE FST CONFIRMED THE REPORTED THERMAL DAMAGE ON THE POWER UNIT BETWEEN THE 24V CONNECTION TO THE MOTHERBOARD. THE FST REMOVED THE POWER SUPPLY AND CONNECTING CABLE FROM STAGE 2 AND INSTALLED THESE COMPONENTS IN STAGE 1. UPON POWERING UP THE RO SYSTEM, THE SECOND POWER SUPPLY FAILED. THE FST REPLACED THE POWER SUPPLY UNITS FOR BOTH STAGES, THE CABLE CONNECTION BETWEEN THE POWER SUPPLY AND MOTHERBOARD, THE MOTHERBOARD, THE FAILSAFE BOARD, AND THE CONNECTING BOARD. THE FST ALSO REPOSITIONED THE BUS TERMINAL JUMPER OF B2 FROM WHERE IT WAS DISCOVERED TO BE IN THE INCORRECT POSITION OF 9B/10B TO THE CORRECT POSITION OF 10B/11B. THE RO SYSTEM WAS RETURNED TO FULL OPERATION FOLLOWING REPAIR. THERE WAS NO PATIENT INVOLVEMENT NOR HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. A PHOTOGRAPH WAS REPORTED TO BE AVAILABLE FOR REVIEW BY THE MANUFACTURER. SAMPLES WERE OBTAINED BY FRESENIUS FOR PHYSICAL EVALUATION BY THE MANUFACTURER.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5 (EVENT DESCRIPTION THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.