AQUABPLUS, B2, HF 1500 KIT

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, 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. 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 TO TECHNICAL SUPPORT (TS) THAT AN AQUABPLUS 1500 WAS EXPERIENCING AN INTERMITTENT T1 TEST FAILURE AND DISPLAYING THE ALARM CODE ¿F-04-51-04¿ WITH A MESSAGE STATING PUMP P1S WAS DEFECTIVE. THE BIOMED WAS ADVISED TO RESET THE SYSTEM¿S POWER. THEY POWERED THE REVERSE OSMOSIS (RO) SYSTEM OFF AND ON, AND THIS TEMPORARILY RESOLVE THE ISSUE. HOWEVER, THE BIOMED CALLED TS BACK AND STATED THE FAILURE CONTINUED TO OCCUR. THE BIOMED WANTED ADVICE ON HOW TO PREVENT THE ISSUE FROM REOCCURRING. AFTER FURTHER TROUBLESHOOTING, THE BIOMED CALLED BACK AND REPORTED THAT THEY FOUND EVIDENCE OF THERMAL DAMAGE AT THE STAGE 2 MOTOR PROTECTION SWITCH (MPS) ON THE WIRES TO THE CONTACTOR. THE BIOMED HAD ORDERED A NEW SWITCH AND WIRES, AND THEY WERE WAITING FOR THE PARTS TO ARRIVE. DURING THE T1 TEST, THE BIOMED ALSO REPORTED THAT THE CONCENTRATE PRESSURE WAS AT 4.9 BAR ON STAGE 2. THE BIOMED WAS ADVISED TO CALIBRATE THE STAGE 2 CONCENTRATE PRESSURE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, AND THUS FAR NO FURTHER DETAILS HAVE BEEN PROVIDED.

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 TO TECHNICAL SUPPORT (TS) THAT AN AQUABPLUS 1500 WAS EXPERIENCING AN INTERMITTENT T1 TEST FAILURE AND DISPLAYING THE ALARM CODE ¿F-04-51-04¿ WITH A MESSAGE STATING PUMP P1S WAS DEFECTIVE. THE BIOMED WAS ADVISED TO RESET THE SYSTEM¿S POWER. THEY POWERED THE REVERSE OSMOSIS (RO) SYSTEM OFF AND ON, AND THIS TEMPORARILY RESOLVE THE ISSUE. HOWEVER, THE BIOMED CALLED TS BACK AND STATED THE FAILURE CONTINUED TO OCCUR. THE BIOMED WANTED ADVICE ON HOW TO PREVENT THE ISSUE FROM REOCCURRING. AFTER FURTHER TROUBLESHOOTING, THE BIOMED CALLED BACK AND REPORTED THAT THEY FOUND EVIDENCE OF THERMAL DAMAGE AT THE STAGE 2 MOTOR PROTECTION SWITCH (MPS) ON THE WIRES TO THE CONTACTOR. THE BIOMED HAD ORDERED A NEW SWITCH AND WIRES, AND THEY WERE WAITING FOR THE PARTS TO ARRIVE. DURING THE T1 TEST, THE BIOMED ALSO REPORTED THAT THE CONCENTRATE PRESSURE WAS AT 4.9 BAR ON STAGE 2. THE BIOMED WAS ADVISED TO CALIBRATE THE STAGE 2 CONCENTRATE PRESSURE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, AND THUS FAR NO FURTHER DETAILS HAVE BEEN PROVIDED.