AQUAC 20 AMP W/SOFTENER

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 FRESENIUS FIELD SERVICE TECHNICIAN (FST) CAME ONSITE AFTER A USER FACILITY REPORTED THAT THE AQUAC REVERSE OSMOSIS (RO) SYSTEM WOULD NOT POWER ON. THE CUSTOMER STATED THAT A POWER SURGE OCCURRED AT THE FACILITY. THE RO SYSTEM WOULD NOT POWER ON AFTER POWER WAS RESTORED. IT IS UNKNOWN WHETHER AN ELECTRICAL STORM OCCURRED IN THE AREA AND LED TO THE POWER SURGE. THE FST STATED THAT THERMAL DECOMPOSITION WAS NOTED ON THE BACKSIDE OF THE POWER SUPPLY UPON EVALUATION OF THE SYSTEM. THE 24V POWER SUPPLY WAS REPLACED TO RESOLVE THE REPORTED ISSUES. THE MACHINE RAN FOR 15 MINUTES WITHOUT ISSUE. THE T1 TEST WAS PASSED. PERMEATE CONDUCTIVITY, PERMEATE TEMPERATURE, FEED WATER CONDUCTIVITY, AND FEED WATER TEMPERATURE WERE TESTED AND FOUND TO BE STABLE. THE ELECTRICAL LEAKAGE TEST PASSED WITH EXPECTED VALUES. THE RO MACHINE WAS RETURNED TO THE CUSTOMER TO BE RETURNED TO SERVICE. THE SAMPLE IS AVAILABLE TO BE 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.

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER THE MANUFACTURER CONFIRMED THE REPORTED ISSUE BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER. ELECTRICAL COMPONENTS AT THE POWER SUPPLY UNIT WERE OVERHEATED AND RESULTED IN THERMAL DAMAGE. THE MANUFACTURER DETERMINED THE DAMAGE WAS CAUSED BY A DESIGN FLAW OF THE POWER SUPPLY BOARD ALONG WITH A POWER SURGE. THE POWER SUPPLY UNIT IS NOT ROBUST ENOUGH AGAINST TEMPORARY POWER SURGES. THIS IS A KNOWN FAILURE. THE ALLEGED DEFECTIVE POWER SUPPLY UNIT IS A SUPPLIER PART. THE POWER SUPPLY UNIT MANUFACTURER HAS ANNOUNCED CORRECTIVE ACTIONS AND A DESIGN IMPROVEMENT IN THE POWER SUPPLY UNIT WAS IMPLEMENTED IN SERIES PRODUCTION IN MAY 2022. THE FAULTY POWER SUPPLY UNIT WAS MANUFACTURED BEFORE THE DESIGN IMPROVEMENT, SO THE NEW IMPROVED POWER SUPPLY DESIGN WAS NOT IMPLEMENTED IN THIS POWER SUPPLY UNIT AT THE TIME OF THE REPORTED FAILURE. THE ISSUE WAS RESOLVED BY REPLACING THE POWER SUPPLY UNIT.

Description of Event or Problem

A FRESENIUS FIELD SERVICE TECHNICIAN (FST) CAME ONSITE AFTER A USER FACILITY REPORTED THAT THE AQUAC REVERSE OSMOSIS (RO) SYSTEM WOULD NOT POWER ON. THE CUSTOMER STATED THAT A POWER SURGE OCCURRED AT THE FACILITY. THE RO SYSTEM WOULD NOT POWER ON AFTER POWER WAS RESTORED. IT IS UNKNOWN WHETHER AN ELECTRICAL STORM OCCURRED IN THE AREA AND LED TO THE POWER SURGE. THE FST STATED THAT THERMAL DECOMPOSITION WAS NOTED ON THE BACKSIDE OF THE POWER SUPPLY UPON EVALUATION OF THE SYSTEM. THE 24V POWER SUPPLY WAS REPLACED TO RESOLVE THE REPORTED ISSUES. THE MACHINE RAN FOR 15 MINUTES WITHOUT ISSUE. THE T1 TEST WAS PASSED. PERMEATE CONDUCTIVITY, PERMEATE TEMPERATURE, FEED WATER CONDUCTIVITY, AND FEED WATER TEMPERATURE WERE TESTED AND FOUND TO BE STABLE. THE ELECTRICAL LEAKAGE TEST PASSED WITH EXPECTED VALUES. THE RO MACHINE WAS RETURNED TO THE CUSTOMER TO BE RETURNED TO SERVICE. THE SAMPLE IS AVAILABLE TO BE 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.