AQUABPLUS, B2, HF 1500 KIT

Description of Event or Problem

AN AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED FINDING THERMAL DAMAGE ON AN AQUABPLUS 1500. THE ORIGINAL ISSUE ENCOUNTERED WITH THE REVERSE OSMOSIS (RO) SYSTEM WAS AN INTERMITTENT POWER-UP ISSUE; THE MACHINE WAS HAVING PROBLEMS STARTING. THE ATOM SAID THE THERMAL OVERLOAD SWITCH WAS TRIPPING IN STAGE 2, AND THE RO WAS DISPLAYING AN "F-02-50-08" ALARM CODE. THE ATOM TRIED FIXING THE MACHINE BY REPLACING THE POWER CONTACTOR, THE THERMAL OVERLOAD RELAY, AND THE POWER SUPPLY BOARD OF STAGE 2. AFTERWARDS, DURING THE T1 TEST, A POWER SURGE OCCURRED WHICH BLEW THE NEW POWER SUPPLY IN STAGE 2. FURTHER TROUBLESHOOTING LED TO A FAULTY MOTOR PROTECTION SWITCH (MPS) IN WHICH THE L1 AND L2 CABLES SHOWED CONTINUITY. UPON FURTHER INSPECTION OF THE RO, THE ATOM DISCOVERED A BURNT CABLE CONNECTED TO THE MPS IN STAGE 2. THE ATOM SAID THAT IT APPEARED BLACKENED. THE ATOM DID NOT NOTICE A BURNING SMELL, AND THERE WERE NO SIGNS OF ANY SMOKE, SPARKS, OR FLAMES. IT WAS CONFIRMED THERE WERE NO BLOWN FUSES IN THE LOCAL POWER SUPPLY, AND THERE WERE NO STORMS OR LOCAL POWER GRID ISSUES THAT COULD HAVE CONTRIBUTED TO THE REPORTED PROBLEM. THE ATOM REPLACED THE MPS AND THE STAGE 2 POWER SUPPLY, AND THE T1 TEST WAS THEN COMPLETED WITHOUT ISSUE. A FEW DAYS LATER, THE ATOM SAID THE RO BEGAN DISPLAYING AN "F¿04¿51¿04" (T1 TEST, PUMP P1S DEFECTIVE) MESSAGE. THE ATOM SAID THE POWER SUPPLY AND MPS HAD ALREADY BEEN REPLACED. AFTER ADDITIONAL TROUBLESHOOTING, IT WAS DISCOVERED THAT THE CONCENTRATE PRESSURE WAS TOO LOW. THE ATOM WAS ABLE TO FIX THE RO BY INCREASING THE CONCENTRATE PRESSURE USING A SCREWDRIVER. UPON FOLLOW-UP, THE MACHINE WAS CONFIRMED TO BE FULLY OPERATIONAL AGAIN. THERE WAS NO PATIENT IMPACT AS A RESULT OF THE REPORTED EVENTS. NO PARTS WERE AVAILABLE TO BE RETURNED FOR EVALUATION, AND NO PHOTOS OF THE BURNT CABLE WERE PROVIDED.

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: B3, B5 PLANT INVESTIGATION: A SAMPLE WAS NOT AVAILABLE FOR MANUFACTURER EVALUATION. ADDITIONALLY, NO PICTURES OF THE THERMAL DAMAGE WERE PROVIDED FOR REVIEW. ACCORDING TO THE AVAILABLE INFORMATION, THERE ARE FOUR FAILURE PATTERNS TO BE CONSIDERED FOR THIS COMPLAINT. THE FIRST IS THE INITIAL OCCURRENCE OF ERROR CODE F-04-51-04 ¿ T1 TEST, PUMP P1S DEFECTIVE DUE TO BAD ELECTRICAL CONTACT BETWEEN THE CABLE LUGS AND THE CONTACT PINS AT THE STAGE 2 MOTOR PROTECTION SWITCH (MPS). THIS FAILURE PATTERN IS KNOWN AND IS COVERED IN A CAPA PROJECT. THE SECOND FAILURE PATTERN IS THE DAMAGED 24 VDC POWER SUPPLY UNIT AT STAGE 2, WHICH WAS CAUSED BY THE POWER SURGE. THE THIRD FAILURE PATTERN IS THE THERMAL DAMAGE ON THE 24 VDC CONNECTOR AT THE POWER SUPPLY DUE TO BAD ELECTRICAL CONTACT. THIS FAILURE PATTERN IS COVERED BY A DIFFERENT CAPA PROJECT. THE FOURTH FAILURE PATTERN IS THE REOCCURRENCE OF ERROR CODE F-04-51-04 ¿ T1 TEST, PUMP P1S DEFECTIVE DUE TO SCALED/BLOCKED MEMBRANES. NO DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED. AFTER REVIEW OF THE PROVIDED MACHINE FILES AND BASED ON THE INFORMATION AVAILABLE, THE REPORTED EVENT WAS ABLE TO BE CONFIRMED.

Description of Event or Problem

AN EMAIL WAS RECEIVED FROM THE AREA TECHNICAL OPERATIONS MANAGER (ATOM) CONTAINING THE MACHINE FILES FROM THE EVENT ALONG WITH OTHER ADDITIONAL DETAILS. DURING THE T1 TEST IN SUPPLY MODE, THE AQUABPLUS WOULD ALARM WITH ¿F-04-51-04¿. DURING THE VISUAL INSPECTION, THERE WERE SIGNS OF HEAT NOTED WITH SOME MODERATE FRAYING. THE ATOM SAID THE POWER SWITCH WAS ALSO REPLACED DUE TO IT SHOWING SIGNS OF HEAT. THE RO RAN FOR A COUPLE OF DAYS WITHOUT HAVING ANY FURTHER ISSUES, AND THEN IT STARTED GIVING THE SAME ERROR MESSAGE AGAIN. AT THAT POINT, THE FACILITY¿S BIOMEDICAL TECHNICIAN (BIOMED) REACHED OUT TO TECHNICAL SUPPORT FOR FURTHER ASSISTANCE. IT WAS SUGGESTED TO THE BIOMED THAT MAYBE THE MEMBRANES WERE SCALED. THE MEMBRANES WERE SUBSEQUENTLY REPLACED THIS THIS RESOLVED THE ISSUE.