AQUABPLUS, B2, HF 1500 KIT

Additional Manufacturer Narrative

PLANT INVESTIGATION: A SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. A REVIEW OF THE MACHINE FILES WAS NOT REQUIRED. TWO DIFFERENT INSTANCES OF THERMAL DAMAGE WERE REPORTED. BOTH WERE FOUND DURING TROUBLESHOOTING OF THE INITIALLY REPORTED POWER ISSUE. THE MOST LIKELY FAILURE CAUSE FOR FAILURE PATTERN 1 WAS 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, THE AFFECTED AQUABPLUS IN THIS COMPLAINT WAS MANUFACTURED PRIOR TO THE CORRECTIVE ACTION BEING IMPLEMENTED. FURTHERMORE, THE NEW DESIGN IS CURRENTLY NOT AVAILABLE ON THE US MARKET. FAILURE PATTERN 2 WAS THE THERMAL DAMAGE FOUND AT THE 24V DC PLUG OF THE POWER SUPPLY UNIT. THIS FAILURE CAN BE CONFIRMED BASED ON PREVIOUS INVESTIGATION RESULTS IN ADDITION TO THE INFORMATION PROVIDED. AN INTERNAL CAPA PROJECT WAS OPENED TO INVESTIGATE THE MANUFACTURING PROCESS OF THE 24V CONNECTORS AT THE POWER SUPPLY UNIT. THERE IS KNOWN TO BE BAD ELECTRICAL CONTACT AT THE CONTACT PIN WHICH RESULTS IN TRANSITION RESISTANCE AND HIGH THERMAL ENERGY. THIS LEADS TO OVERHEATING AND DISCOLORATION. THE PRODUCTION PROCESS WAS IMPROVED WITHIN THE CAPA PROJECT, AND THE CORRECTIVE ACTIONS WERE IMPLEMENTED. HOWEVER, THE AFFECTED DEVICE WAS MANUFACTURED BEFORE IMPLEMENTATION. BASED ON THE INFORMATION AVAILABLE, THE REPORTED EVENT WAS ABLE TO BE CONFIRMED.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED THAT AN AQUABPLUS 1500 WOULD NOT POWER ON AND THERMAL DAMAGE WAS FOUND DURING EVALUATION OF THE REVERSE OSMOSIS (RO) SYSTEM. THE BIOMED WAS CONTACTED BY STAFF FROM THE HEMODIALYSIS (HD) CLINIC BEFORE OPENING BECAUSE THE RO WOULD NOT TURN ON. THERE WERE NO KNOWN ALARM CODES DUE TO THE EVENT. THE BIOMED CONFIRMED THE SYSTEM WAS NOT POWERING ON WHEN THEY ARRIVED ONSITE. THERE WERE NO BLOWN FUSES IN THE LOCAL POWER SUPPLY, AND THE MOTOR PROTECTION SWITCH (MPS) WAS NOT TRIPPING. THERE WERE NO SIGNS OF SMOKE, SPARKS, OR FLAMES, AND NO REPORTS OF A BURNING SMELL. THE BIOMED ALSO CONFIRMED THERE WERE NO LOCAL POWER GRID ISSUES AROUND THE TIME OF THE EVENT. DURING EVALUATION OF THE RO, THE BIOMED NOTICED THERE WERE SIGNS OF HEAT ON THE INSULATION OF THE MAIN RED AND BLUE POWER CABLE BEHIND THE MPS, BETWEEN THE POWER SUPPLY AND THE MOTHERBOARD. THE BIOMED SAID THIS CABLE SHOWED SIGNS OF CHARRING. THE BIOMED ALSO NOTICED DISCOLORATION ON THE PLASTIC COVERINGS (OR CABLE LUGS) OF THE L1, L2, AND L3 SPADE CONNECTORS. AFTER THOROUGH INSPECTION AND SEVERAL ROUNDS OF ATTEMPTING TO RESET THE RO, THE DISPLAY SCREEN RANDOMLY CAME ON. THE BIOMED SAID THE RO CAME ON BEFORE THE CLINIC OPENED AND WAS ABLE TO BE USED ALL DAY. THE BIOMED WAS ABLE TO FIX THE MACHINE BY REPLACING THE RED AND BLUE POWER SUPPLY CABLE AS WELL AS THE POWER SUPPLY BOARD. THE BIOMED REPLACED THE MPS WITH A SPARE THEY HAD ON HAND, AND THEY ALSO ORDERED NEW SPADE CONNECTORS. THE BIOMED WAS PLANNING TO REPLACE THE SPADE CONNECTORS ONCE THEY ARRIVED. THE BIOMED SAID THE MACHINE REPAIR HAS BEEN COMPLETED AND THE RO IS FULLY OPERATIONAL. THERE WAS NO NEGATIVE PATIENT IMPACT. THE BIOMED DID NOT HAVE ANY PHOTOS OF THE DAMAGED PARTS, AND NO PARTS WERE AVAILABLE TO BE RETURNED FOR EVALUATION AS THEY WERE REPORTEDLY DISCARDED. THE BIOMED WAS ALSO UNABLE TO PROVIDE FTP FILES.

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 THAT AN AQUABPLUS 1500 WOULD NOT POWER ON AND THERMAL DAMAGE WAS FOUND DURING EVALUATION OF THE REVERSE OSMOSIS (RO) SYSTEM. THE BIOMED WAS CONTACTED BY STAFF FROM THE HEMODIALYSIS (HD) CLINIC BEFORE OPENING BECAUSE THE RO WOULD NOT TURN ON. THERE WERE NO KNOWN ALARM CODES DUE TO THE EVENT. THE BIOMED CONFIRMED THE SYSTEM WAS NOT POWERING ON WHEN THEY ARRIVED ONSITE. THERE WERE NO BLOWN FUSES IN THE LOCAL POWER SUPPLY, AND THE MOTOR PROTECTION SWITCH (MPS) WAS NOT TRIPPING. THERE WERE NO SIGNS OF SMOKE, SPARKS, OR FLAMES, AND NO REPORTS OF A BURNING SMELL. THE BIOMED ALSO CONFIRMED THERE WERE NO LOCAL POWER GRID ISSUES AROUND THE TIME OF THE EVENT. DURING EVALUATION OF THE RO, THE BIOMED NOTICED THERE WERE SIGNS OF HEAT ON THE INSULATION OF THE MAIN RED AND BLUE POWER CABLE BEHIND THE MPS, BETWEEN THE POWER SUPPLY AND THE MOTHERBOARD. THE BIOMED SAID THIS CABLE SHOWED SIGNS OF CHARRING. THE BIOMED ALSO NOTICED DISCOLORATION ON THE PLASTIC COVERINGS (OR CABLE LUGS) OF THE L1, L2, AND L3 SPADE CONNECTORS. AFTER THOROUGH INSPECTION AND SEVERAL ROUNDS OF ATTEMPTING TO RESET THE RO, THE DISPLAY SCREEN RANDOMLY CAME ON. THE BIOMED SAID THE RO CAME ON BEFORE THE CLINIC OPENED AND WAS ABLE TO BE USED ALL DAY. THE BIOMED WAS ABLE TO FIX THE MACHINE BY REPLACING THE RED AND BLUE POWER SUPPLY CABLE AS WELL AS THE POWER SUPPLY BOARD. THE BIOMED REPLACED THE MPS WITH A SPARE THEY HAD ON HAND, AND THEY ALSO ORDERED NEW SPADE CONNECTORS. THE BIOMED WAS PLANNING TO REPLACE THE SPADE CONNECTORS ONCE THEY ARRIVED. THE BIOMED SAID THE MACHINE REPAIR HAS BEEN COMPLETED AND THE RO IS FULLY OPERATIONAL. THERE WAS NO NEGATIVE PATIENT IMPACT. THE BIOMED DID NOT HAVE ANY PHOTOS OF THE DAMAGED PARTS, AND NO PARTS WERE AVAILABLE TO BE RETURNED FOR EVALUATION AS THEY WERE REPORTEDLY DISCARDED. THE BIOMED WAS ALSO UNABLE TO PROVIDE FTP FILES.