AQUABPLUS, B2, HF 1500 KIT

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED FINDING THERMAL DAMAGE ON THE L3 WIRE CONNECTOR AT THE STAGE 2 MOTOR PROTECTION SWITCH (MPS) OF AN AQUABPLUS 1500. THE SYSTEM WAS IN SUPPLY MODE WHEN THE EVENT OCCURRED. THE EVENT OCCURRED ON A NON-TREATMENT DAY, SO THERE WAS NO PATIENT INVOLVEMENT. THE REVERSE OSMOSIS (RO) SYSTEM STARTED UP FINE, BUT IT TOOK A WHILE TO GO THROUGH THE T1 TEST. THE RO WAS TURNED OFF AND BACK ON, AND WHEN IT CAME BACK ON A ¿PUMP P1S DEFECTIVE¿ MESSAGE APPEARED WITH THE ALARM CODE ¿F-04-51-04¿. THE BIOMED CALLED TECHNICAL SUPPORT (TS) FOR TROUBLESHOOTING ASSISTANCE. THE PUMP (P1) WAS NOT RUNNING AT THE TIME OF THE CALL. THE BIOMED CONFIRMED THE VOLTAGE WAS SUFFICIENT BETWEEN THE WIRE CONNECTIONS, MEASURING AT APPROXIMATELY 220 VOLTS. UPON FOLLOW-UP WITH THE BIOMED, IT WAS CONFIRMED THERE WERE NO ISSUES WITH STAGE 1. THE BIOMED SAID THE FAILURE SEEMED TO BE OCCURRING IN STAGE 2. THE BIOMED SAID WHEN THE STAGE 1 PUMP RAN, THEY PRESSED THE BLACK BUTTON ON THE STAGE 2 CONTACTOR AND THE STAGE 2 PUMP DID NOT INITIATE. UPON FURTHER EVALUATION IT WAS DISCOVERED THAT THE STAGE 2 CONTACTOR WAS ¿STUCK¿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

Additional Manufacturer Narrative

PLANT INVESTIGATION: A SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. HOWEVER, THE MANUFACTURER INDICATED THAT A SAMPLE RETURN WAS NOT REQUIRED. A REVIEW OF SIMILAR COMPLAINTS WAS ALSO NOT REQUIRED. THE REPORTED EVENT CAN BE CONFIRMED BASED ON THE PROVIDED INFORMATION. NO DEVICE HISTORY RECORD (DHR) REVIEW WAS REQUIRED, AND NO REPRODUCTION OF THE FAILURE WAS FOUND TO BE NECESSARY. A REVIEW OF THE MACHINE FILES WAS ALSO NOT REQUIRED. THE REPORTED EVENT CAN BE ATTRIBUTED TO A CAPA PROJECT. THE THERMAL DAMAGE WAS LIKELY CAUSED BY BAD ELECTRICAL CONTACT AT THE MOTOR PROTECTION SWITCH (MPS). INCREASED CONTACT RESISTANCE LIKELY LED TO A RISE IN THERMAL ENERGY AT THE CONTACT POINTS. WHEN THIS HAPPENS THE CABLE LUGS/WIRING AT THE MPS BECOME OVERHEATED, WHICH LEADS TO DISCOLORATION/DAMAGE AT THE BAD ELECTRICAL CONTACT POINT. THIS CAN CAUSE THE THERMAL OVERLOAD SWITCH OR THE MPS (DEPENDING ON THE OPERATION MODE) TO TRIP. THE FAILURE PATTERN IS KNOWN AND A CAPA WAS OPENED TO ADDRESS THE ISSUE. AS A CORRECTIVE ACTION FROM THE CAPA PROJECT, A NEW DESIGN OF THE MPS AND ITS WIRING WAS DEVELOPED AND RELEASED. HOWEVER, IT IS CURRENTLY NOT AVAILABLE ON THE US MARKET. BASED ON THE INFORMATION AVAILABLE, THE REPORTED EVENT WAS ABLE TO BE CONFIRMED.