AQUABPLUS, B2, HF 1500 KIT

Description of Event or Problem

A USER FACILITY AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED TO FRESENIUS THAT THERMAL DAMAGE WAS DISCOVERED ON THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. A WIRE CONNECTING THE STAGE 1 MOTOR PROTECTION SWITCH TO THE CONTACTOR WAS BLACK WITH DARKENED INSULATION. THE REPORTED ISSUE WAS DISCOVERED DURING MACHINE REPAIR AFTER THERE WAS NO POWER TO THE RO SYSTEM IN SUPPLY MODE. THERE WERE NO ASSOCIATED ALARM CODES. IT WAS NOTED THAT THE SCREEN WAS DARK. IT WAS VERIFIED THAT THE RO SYSTEM HAD ALL THREE PHASES OF POWER. A BLOWN FUSE (3.15A) WAS IDENTIFIED ON THE HOT TO THE 24VDC POWER SUPPLY BOARD. THE FUSE WAS REPLACED AND THE NEUTRAL BLEW AS SOON WAS POWER WAS RESTORED. THE 24 VDC POWER SUPPLY BOARD IN STAGE 2 WAS SWAPPED TO STAGE 1. THE RO SYSTEM WAS ABLE TO PASS THE T1 TEST FOR SUPPLY MODE. IT WAS RECOMMENDED TO THE ATOM THAT THE 24 VDC BOARD IN STAGE 2 BE REPLACED ALONG WITH THE BLACK WIRE IN STAGE 1. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING THAT OCCURRED AS A RESULT OF THE IDENTIFIED THERMAL DAMAGE. IT WAS CONFIRMED THAT STORMS OCCURRED IN THE AREA AND THE CLINIC EXPERIENCED LOCAL POWER GRID ISSUES ON OR AROUND THE REPORTED EVENT DATE. THE THERMAL OVERLOAD RELAY DID NOT TRIP. THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. NO BLOWN FUSES WERE IDENTIFIED IN THE LOCAL POWER SUPPLY (EQUIPPED WITH 25-AMP FUSES). THE ATOM INDICATED THAT THE STAGE 1 POWER BOARD AND FUSES WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM HAS BEEN RETURNED TO SERVICE. THERE WAS NO PERSONAL HARM TO ANYONE AS A RESULT OF DISCOVERING THE THERMAL DAMAGE. THE COMPLAINT SAMPLE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, H3 PLANT INVESTIGATION: A PHOTOGRAPH WAS PROVIDED BY THE CUSTOMER FOR EVALUATION BY THE MANUFACTURER. THE MANUFACTURER WAS ABLE TO CONFIRM THE REPORTED ISSUE USING THE PHOTOGRAPH AS WELL AS THE PROVIDED INFORMATION. THE THERMAL DAMAGE WAS CAUSED BY LOW CONTACT PRESSURE WHICH RESULTED IN CONTACT RESISTANCE AT THE BAD CONTACTED POINT AND A HIGH THERMAL POWER LOSS WAS INDICATED, NOTED AS THE THERMAL DAMAGE. THIS FAILURE PATTERN IS KNOWN AND COVERED BY AN INTERNAL CAPA PROJECT. CORRECTIVE ACTIONS OF THE CAPA WERE DEFINED AND IMPLEMENTED. THE DESIGN OF THE CRIMPED CABLE LUG WAS CHANGED. THE AFFECTED DEVICE WAS BUILT BEFORE THE IMPLEMENTATION OF THE CAPA AND WAS STILL EQUIPPED WITH THE OLD DESIGN OF THE CRIMPED CABLE LUG AT TIME OF THE FAILURE ACCORDING TO THE PROVIDED PICTURE. ACCORDING TO THE COMPLAINT INTAKE INFORMATION IT WAS RECOMMENDED TO REPLACE THE AFFECTED CABLE LUG AND WIRING. NO INFORMATION IS AVAILABLE TO CONFIRM WHETHER THIS WAS DONE. IT IS THEREFORE RECOMMENDED TO PREVENTIVELY REPLACE THE MOTOR PROTECTION SWITCH AND THE CORRESPONDING WIRING.

Description of Event or Problem

A USER FACILITY AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED TO FRESENIUS THAT THERMAL DAMAGE WAS DISCOVERED ON THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. A WIRE CONNECTING THE STAGE 1 MOTOR PROTECTION SWITCH TO THE CONTACTOR WAS BLACK WITH DARKENED INSULATION. THE REPORTED ISSUE WAS DISCOVERED DURING MACHINE REPAIR AFTER THERE WAS NO POWER TO THE RO SYSTEM IN SUPPLY MODE. THERE WERE NO ASSOCIATED ALARM CODES. IT WAS NOTED THAT THE SCREEN WAS DARK. IT WAS VERIFIED THAT THE RO SYSTEM HAD ALL THREE PHASES OF POWER. A BLOWN FUSE (3.15A) WAS IDENTIFIED ON THE HOT TO THE 24VDC POWER SUPPLY BOARD. THE FUSE WAS REPLACED AND THE NEUTRAL BLEW AS SOON WAS POWER WAS RESTORED. THE 24 VDC POWER SUPPLY BOARD IN STAGE 2 WAS SWAPPED TO STAGE 1. THE RO SYSTEM WAS ABLE TO PASS THE T1 TEST FOR SUPPLY MODE. IT WAS RECOMMENDED TO THE ATOM THAT THE 24 VDC BOARD IN STAGE 2 BE REPLACED ALONG WITH THE BLACK WIRE IN STAGE 1. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING THAT OCCURRED AS A RESULT OF THE IDENTIFIED THERMAL DAMAGE. IT WAS CONFIRMED THAT STORMS OCCURRED IN THE AREA AND THE CLINIC EXPERIENCED LOCAL POWER GRID ISSUES ON OR AROUND THE REPORTED EVENT DATE. THE THERMAL OVERLOAD RELAY DID NOT TRIP. THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. NO BLOWN FUSES WERE IDENTIFIED IN THE LOCAL POWER SUPPLY (EQUIPPED WITH 25-AMP FUSES). THE ATOM INDICATED THAT THE STAGE 1 POWER BOARD AND FUSES WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM HAS BEEN RETURNED TO SERVICE. THERE WAS NO PERSONAL HARM TO ANYONE AS A RESULT OF DISCOVERING THE THERMAL DAMAGE. THE COMPLAINT SAMPLE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.