AQUABPLUS, B2, HF 1500 KIT

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER THE REPORTED ISSUE WAS CONFIRMED BY THE MANUFACTURER USING THE INFORMATION AND PHOTOGRAPH PROVIDED BY THE CUSTOMER. THE CAUSE IS DETERMINED TO BE A BAD ELECTRICAL CONTACT AT THE CONTACT PIN WHICH CAUSES TRANSITION RESISTANCE AND HIGH THERMAL ENERGY. THIS RESULTS IN AN OVERHEATED AND DISCOLORED 24V CONNECTION CABLE/PLUG. DUE TO THE BAD ELECTRICAL CONTACT, VOLTAGE IS LOST AND THE MACHINE WAS NOT ABLE TO POWER ON. THE THERMAL DAMAGE AT 24V CONNECTION CABLE/PLUG WAS FOUND DURING TROUBLESHOOTING THE INITIAL POWER FAILURE FOLLOWING A POWER OUTAGE THAT OCCURRED AT THE FACILITY. THIS FAILURE IS A KNOWN ISSUE. CORRECTIVE ACTIONS HAVE BEEN DEFINED AND IMPLEMENTED. THE PRODUCTION PROCESS WAS IMPROVED IN APRIL 2023. ONLY DEVICES AND SPARE PARTS MANUFACTURED SINCE APRIL 2023 COULD WILL INCLUDE THE IMPROVED PROCESS. THE AFFECTED DEVICE WAS MANUFACTURED IN 2015, BEFORE IMPLEMENTING THE CORRECTIONS IN SERIES PRODUCTION. ACCORDING TO THE INTAKE INFORMATION THE ISSUE WAS SOLVED BY THE REPLACEMENT OF THE POWER SUPPLY UNIT AND THE POWER SUPPLY CABLE.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT A POWER OUTAGE OCCURRED AT THE FACILITY AND THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM WOULD NOT POWER ON AFTER POWER WAS RESTORED. THE GREEN POWER SWITCH WAS ON. THE BIOMED MEASURED 208 VOLTS AC AT THE BACK OF THE MOTOR PROTECTION SWITCH (BETWEEN THE WIRES AT THE BOTTOM). THE BIOMED CHECKED THE INSIDE OF THE ELECTRONIC PANEL AND THE RED/BLUE POWER SUPPLY CONNECTOR WAS NOTED TO BE CHARRED. THE REPORTED ISSUE WAS CONFIRMED DURING FOLLOW-UP AND ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THE BIOMED STATED THAT REPOSITIONING THE POWER SUPPLY CABLE ALLOWS THE RO SYSTEM TO POWER ON AND PASS THE T1 TEST. THE AREA TECHNICAL OPERATIONS MANAGER (ATOM) CAME ONSITE AND REPLACED THE POWER SUPPLY BOARD AND THE POWER SUPPLY CABLE. THE RO SYSTEM WAS RETURNED TO SERVICE. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. IT WAS NOTED THAT NO BLOWN FUSES WERE DISCOVERED, THE THERMAL OVERLOAD RELAY DID NOT TRIP, AND THERE WERE NO ELECTRICAL STORMS IN THE AREA ON OR AROUND THE REPORTED EVENT DATE. THE BIOMED NOTED THAT A HOSPITAL LOCATED UP THE ROAD FROM THE FACILITY IS UNDERGOING CONSTRUCTION WHICH IS SUSPECTED TO BE THE CAUSE OF THE INITIAL POWER ISSUE.

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 A POWER OUTAGE OCCURRED AT THE FACILITY AND THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM WOULD NOT POWER ON AFTER POWER WAS RESTORED. THE GREEN POWER SWITCH WAS ON. THE BIOMED MEASURED 208 VOLTS AC AT THE BACK OF THE MOTOR PROTECTION SWITCH (BETWEEN THE WIRES AT THE BOTTOM). THE BIOMED CHECKED THE INSIDE OF THE ELECTRONIC PANEL AND THE RED/BLUE POWER SUPPLY CONNECTOR WAS NOTED TO BE CHARRED. THE REPORTED ISSUE WAS CONFIRMED DURING FOLLOW-UP AND ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THE BIOMED STATED THAT REPOSITIONING THE POWER SUPPLY CABLE ALLOWS THE RO SYSTEM TO POWER ON AND PASS THE T1 TEST. THE AREA TECHNICAL OPERATIONS MANAGER (ATOM) CAME ONSITE AND REPLACED THE POWER SUPPLY BOARD AND THE POWER SUPPLY CABLE. THE RO SYSTEM WAS RETURNED TO SERVICE. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. IT WAS NOTED THAT NO BLOWN FUSES WERE DISCOVERED, THE THERMAL OVERLOAD RELAY DID NOT TRIP, AND THERE WERE NO ELECTRICAL STORMS IN THE AREA ON OR AROUND THE REPORTED EVENT DATE. THE BIOMED NOTED THAT A HOSPITAL LOCATED UP THE ROAD FROM THE FACILITY IS UNDERGOING CONSTRUCTION WHICH IS SUSPECTED TO BE THE CAUSE OF THE INITIAL POWER ISSUE.