AQUABPLUS 1500 B2 1000

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED SEEING A SPARK AND THEN A PUFF OF SMOKE AFTER RESETTING THE STAGE 1 THERMAL OVERLOAD SWITCH ON THIS AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. PRIOR TO THIS OCCURRING, THE RO DISPLAYED AN ERROR MESSAGE (¿F¿04¿50¿04 FAILURE: T1 TEST, PUMP P1 DEFECTIVE¿) AND THEN THE MACHINE POWERED OFF. UPON FOLLOW-UP, THE BIOMED COULD NOT RECALL IF THERE WERE ANY LOCAL POWER GRID ISSUES AND/OR STORMS AROUND THE TIME OF THE EVENT. THE BIOMED SAID THE CLINIC HAD ALREADY CLOSED FOR THE DAY, AND THEREFORE NO TREATMENTS WERE IMPACTED. THE RO WAS IN RINSE MODE WHEN THE EVENT OCCURRED. IT WAS REPORTED THAT THE THERMAL OVERLOAD SWITCH TRIPPED IN STAGE 1. THE BIOMED NOTED THAT THE SWITCH DID NOT HAVE A PAST HISTORY OF TRIPPING. THE BIOMED TRIED RESETTING THE SWITCH TO RESOLVE THE ISSUE. THEY (PARTIALLY) SET THE COVER BACK DOWN, HIT THE ON BUTTON, AND THEN SAW A SPARK FOLLOWED BY A PUFF OF SMOKE. THE AMOUNT OF SMOKE WAS NOT SUBSTANTIAL, AND THEREFORE THE SMOKE DETECTOR DID NOT GO OFF. UPON FURTHER EVALUATION, THE BIOMED FOUND THE STAGE 1 MOTOR PROTECTION SWITCH (MPS) TO BE BURNT. THE BIOMED ALSO NOTICED THE LEADS ON ALL CONNECTED WIRES (L1, L2, AND L3) WERE BURNT, AND ONE OF THE STUDS ON THE SWITCH HAD BROKEN OFF. THERE WERE NO BLOWN FUSES IN THE LOCAL POWER SUPPLY. THE BIOMED WAS ABLE TO REPAIR THE MACHINE BY REPLACING THE MPS AND CUTTING OFF THE BURNT PIECES OF WIRE. THE BIOMED ALSO ORDERED NEW CABLES WHICH HAD NOT YET ARRIVED AT THE TIME OF FOLLOW-UP. THE MACHINE WAS CONFIRMED TO BE FULLY OPERATIONAL AGAIN. THE BIOMED COULD NOT PROVIDE THE FTP MACHINE FILES. THE DAMAGED PARTS WERE DISCARDED AND NO SAMPLES WERE AVAILABLE FOR EVALUATION. HOWEVER, PHOTOS OF THE DAMAGED PARTS WERE PROVIDED FOR REVIEW.

Additional Manufacturer Narrative

PLANT INVESTIGATION: A SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. HOWEVER, THE MANUFACTURER INDICATED THAT A SAMPLE INVESTIGATION WAS NOT REQUIRED. A REVIEW OF SIMILAR COMPLAINTS WAS ALSO NOT REQUIRED. THE REPORTED EVENT WAS CONFIRMED BASED ON THE AVAILABLE INFORMATION ALONG WITH THE PHOTOS PROVIDED. NO DEVICE HISTORY RECORD (DHR) REVIEW WAS REQUIRED, AND A REPRODUCTION OF THE FAILURE WAS FOUND TO BE UNNECESSARY. A REVIEW OF THE MACHINE FILES WAS ALSO NOT REQUIRED. THE REPORTED EVENT CAN BE ATTRIBUTED TO A CAPA PROJECT. THE REPORTED ISSUE WAS LIKELY CAUSED BY BAD ELECTRICAL CONTACT WHICH LED TO INCREASED CONTACT RESISTANCE AND A RISE IN THERMAL ENERGY AT THE CONTACT POINTS. WHEN THIS HAPPENS THE CABLE LUGS/WIRING AT THE MOTOR PROTECTION SWITCH (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. THIS COULD TRIGGER THE REPORTED FAILURE CODE THAT OCCURRED (¿F-04-50-04 T1-TEST, PUMP P1 DEFECTIVE¿) EFFECTIVELY INTERRUPTING OPERATION OF THE DEVICE. AN ADDITIONAL CONTRIBUTING FACTOR FOR A TRIPPED MPS OR THERMAL OVERLOAD RELAY COULD BE POWER ISSUES WHICH CAUSE HIGHER CURRENTS. 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, THE AFFECTED AQUABPLUS IN THIS COMPLAINT WAS MANUFACTURED PRIOR TO THE CORRECTIVE ACTION BEING IMPLEMENTED. BASED ON THE INFORMATION AVAILABLE, THE REPORTED EVENT WAS ABLE TO BE CONFIRMED.