AQUABPLUS, B2, HF 1500 KIT

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 FINDING THERMAL DAMAGE ON AN AQUABPLUS 1500. THE BIOMED STATED THE REVERSE OSMOSIS (RO) MACHINE WOULD NOT START UP ONE MORNING. THIS OCCURRED BEFORE THE CLINIC HAD OPENED AND NO TREATMENTS WERE IMPACTED. THE BIOMED SAID THERE HAD BEEN STORMS IN THE AREA AROUND THE TIME OF THE EVENT. THE BIOMED SAID THE CLINIC LOST POWER AND WAS RUNNING ON A GENERATOR UNTIL THE FOLLOWING DAY. IT WAS REPORTED THAT AN ERROR OCCURRED IN STAGE 1 (F-04-51-04) INDICATING THAT PUMP P1 WAS DEFECTIVE. UPON FURTHER INSPECTION, THE BIOMED NOTICED THE YELLOW WIRE CONNECTORS ON THE MOTOR PROTECTION SWITCH (MPS) WERE BURNT. THE BIOMED SAID SPARE WIRE KITS AND MOTOR PROTECTION SWITCHES ARE KEPT IN STOCK. THEY REPLACED THE STAGE 1 MPS AND ITS CONNECTED WIRES, BUT THEY COULDN¿T GET IT TO PASS THE T1 TEST. THE BIOMED THEN TRIED RUNNING THE AQUABPLUS IN STAGE 2, BUT STAGE 2 ALSO WASN¿T WORKING. THE BIOMED THEN DISCOVERED THAT THE YELLOW WIRE CONNECTORS ON THE STAGE 2 MPS WERE ALSO BURNT. THE MPS AND WIRE KIT WERE THEN REPLACED ON THIS STAGE AS WELL. THERE WAS NO EVIDENCE OF ANY BURNING SMELL, SMOKE, SPARKS, OR FLAMES. THE BIOMED SAID SOME OF THE BURNT WIRE CONNECTORS HAD EVEN MELTED TO THE MPS. IT WAS NOT SPECIFIED HOW MANY BURNT CONNECTORS WERE FOUND, OR AT WHICH STAGE THE MELTED CONNECTORS WERE NOTED. NO OTHER COMPONENTS WERE FOUND TO BE DAMAGED. THOUGH IT DID NOT WORK RIGHT AWAY, THE BIOMED WAS EVENTUALLY ABLE TO GET THE SYSTEM RUNNING IN EMERGENCY MODE 2. THE BIOMED CONFIRMED THE THERMAL OVERLOAD SWITCH WAS NOT TRIPPING. IN FACT, THEY SAID THAT EVEN THE MOTOR PROTECTION SWITCHES WERE NOT TRIPPING. DURING TROUBLESHOOTING, THE BIOMED SAID THE MACHINE WOULD JUST ¿SIT IN THE T1 TEST, AND THEN FAIL¿. IT WAS CONFIRMED THAT THE RO WAS NOW FULLY OPERATIONAL. THE BIOMED THOUGHT THIS ¿NEWER VERSION¿ OF THE MPS AND WIRE KITS WOULD LAST LONGER THAN THEY DID. THE BIOMED DID NOT HAVE ANY PHOTOS OF THE DAMAGED PARTS, AND THE PARTS WERE DISCARDED. FTP FILES WERE NOT AVAILABLE. THE BIOMED DID NOT DOWNLOAD THEM BECAUSE THEY WERE ABLE TO GET THE ISSUE RESOLVED ON THEIR OWN IN A TIMELY MANNER. THEY SAID IT WAS HELPFUL TO HAVE THE SPARE PARTS ON HAND.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5 THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

Description of Event or Problem

THE BIOMED PROVIDED CLARIFICATION ON THE ALARM CODE TRIGGERED BY THE MACHINE. THE BIOMED STATED THE ALARM CODE WAS F-04-50-04, NOT F-04-51-04.

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE COMPLAINT INVESTIGATION CONTAINS TWO FAILURE PATTERNS. THE INITIAL FAILURE PATTERN WAS THE ERROR CODE F-04-50-04, WHICH WAS MOST LIKELY CAUSED BY MISSING/FLUCTUATION LINE CONDUCTORS AND CAN BE CONFIRMED BY THE INTAKE INFORMATION. THE SECOND FAILURE PATTERN CAN BE CONFIRMED BASED ON KNOWLEDGE FROM PREVIOUS COMPLAINT INVESTIGATIONS, AS WELL AS THE INTAKE INFORMATION. THE REPORTED EVENT CAN BE ATTRIBUTED TO THE FAILURE PATTERN OF BAD ELECTRICAL CONTACTING BETWEEN THE CABLE LUGS AND THEIR CONTACT PINS AT THE MOTOR PROTECTION SWITCH (MPS). THE THERMAL DAMAGE WAS MOST LIKELY CAUSED BY BAD ELECTRICAL CONTACT AT THE MPS. THE CONTACT RESISTANCE INCREASED, AND THE PUMP CURRENT LED TO INCREASED THERMAL ENERGY AT THE CONTACTS POINTS. THE CABLE LUGS AT THE MPS GET OVERHEATED AND DISCOLORED BY THE RELEASED THERMAL ENERGY AT THE BAD ELECTRICAL CONTACTING POINTS. AS A RESULT, THE THERMAL OVERLOAD SWITCH COULD TRIP AND INTERRUPT THE DEVICE¿S OPERATION. THE CONCERNED WIRES WITH THE INCLUDED CABLE LUGS ARE SUPPLIER PARTS. A MANUFACTURING FAILURE CANNOT BE EXCLUDED OR CONFIRMED AS A POSSIBLE FAILURE CAUSE. AS NO DEFECTIVE PARTS WERE PROVIDED, NO SUPPLIER NON-CONFORMITY CAN BE SUBMITTED. ACCORDING TO THE INTAKE INFORMATION, THE ISSUE WAS RESOLVED ONSITE BY REPLACING THE MPS AND WIRING.

Description of Event or Problem

THE BIOMED PROVIDED CLARIFICATION ON THE ALARM CODE TRIGGERED BY THE MACHINE. THE BIOMED STATED THE ALARM CODE WAS F-04-50-04, NOT F-04-51-04.