AQUABPLUS, B2, HF 2000 KIT

Additional Manufacturer Narrative

PLANT INVESTIGATION: ALTHOUGH A SAMPLE WAS REPORTEDLY AVAILABLE FOR EVALUATION, THE MANUFACTURER INDICATED THAT A SAMPLE RETURN WAS NOT REQUIRED. A REVIEW OF SIMILAR COMPLAINTS WAS ALSO NOT REQUIRED. THE FAILURE CAUSE WAS ABLE TO BE DETERMINED BASED ON THE INFORMATION PROVIDED AS WELL AS KNOWLEDGE FROM PREVIOUS COMPLAINT INVESTIGATIONS. NO DEVICE HISTORY RECORD (DHR) REVIEW WAS REQUIRED, AND NO REPRODUCTION OF THE FAILURE WAS FOUND TO BE NECESSARY. THE THERMAL DAMAGE WAS 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. THE CABLE LUGS/WIRING AT THE MPS BECOMES OVERHEATED WHEN THIS HAPPENS, 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. A DESIGN CHANGE FOR A DIFFERENT MPS AND ELECTRICAL CONNECTION WAS SUBMITTED. HOWEVER, THE DESIGN CHANGE PROCESS HAS NOT BEEN COMPLETED AND 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 FINDING THERMAL DAMAGE AT THE STAGE 2 MOTOR PROTECTION SWITCH (MPS) OF AN AQUABPLUS 2000. THE BIOMED SAID THE ORIGINAL ISSUE WAS THAT THE REVERSE OSMOSIS (RO) WAS RANDOMLY POWERING OFF IN STAGE 1. THE MACHINE WAS IN SUPPLY MODE AT THE TIME. THE BIOMED WAS UNABLE TO POWER IT BACK ON AND KEEP IT POWERED ON. WHENEVER THE SYSTEM WAS ON LONG ENOUGH FOR THE BIOMED TO GET IT INTO STANDBY MODE, IT WOULD TRIP BEFORE THE T1 TEST WAS ABLE TO BE PERFORMED. THE BIOMED SAID THERE WERE NO ALARM CODES ASSOCIATED WITH THE FAILURE. THERE WAS NO VISIBLE DAMAGE NOTED AT THE STAGE 1 MPS. THE BIOMED DECIDED TO REPLACE THE STAGE 1 MPS WITH THE STAGE 2 MPS. HOWEVER, WHEN THE BIOMED WENT TO REMOVE THE STAGE 2 MPS, THEY FOUND SIGNIFICANT THERMAL DAMAGE ON THE CONNECTORS. THE BIOMED NOTED BURN DAMAGE AND BUBBLING ON THE COMPONENTS. ONE OF THE CONNECTORS WAS MELTED TO THE SWITCH, AND THE BIOMED STRUGGLED TO ¿RIP IT OFF¿. THE BIOMED STATED THERE WERE NO SIGNS OF ANY SMOKE, SPARKS, OR FLAMES. THERE WERE NO REPORTS OF A BURNING SMELL EITHER. THE BIOMED CONFIRMED THERE WERE NO BLOWN FUSES IN THE LOCAL POWER SUPPLY, AND THERE WERE NO LOCAL POWER GRID ISSUES AROUND THE TIME OF THE EVENT. IT WAS UNKNOWN WHAT THE CAUSE OF THE ORIGINAL FAILURE WAS. THE BIOMED WAS ABLE TO REPAIR THE RO BY REPLACING THE MOTOR PROTECTION SWITCHES FROM BOTH STAGE 1 AND STAGE 2. THE BIOMED CONFIRMED THE MACHINE WAS REPAIRED THE SAME DAY AND REMAINS FULLY OPERATIONAL. ALTHOUGH THE RO WAS IN SUPPLY MODE AT THE TIME OF THE FAILURE, THE BIOMED CONFIRMED THERE WERE NO ADVERSE EVENTS DUE TO THE REPORTED ISSUE. SOME OF THE TREATMENTS FROM THE FIRST SHIFT WERE CUT SHORT, BUT THIS DID NOT HAVE ANY NEGATIVE PATIENT IMPACT. THERE WERE NO INSTANCES OF PATIENTS EXPERIENCING ANY ADVERSE EFFECTS OR REQUIRING MEDICAL INTERVENTION. PHOTOS OF THE DAMAGED COMPONENTS WERE SAID TO BE AVAILABLE BUT HAVE NOT YET BEEN PROVIDED. BOTH MOTOR PROTECTION SWITCHES WERE CONFIRMED TO BE AVAILABLE FOR MANUFACTURER EVALUATION.