AQUABPLUS, B2, HF 2000 KIT

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT INDICATIONS OF BURNT OR CHARRED WIRING WAS PRESENT WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE REPORTED ISSUE WAS DISCOVERED DURING TROUBLESHOOTING. THE BIOMED INITIALLY CONTACTED FRESENIUS WITH ASSISTANCE AFTER THE T1 TEST FAILED. ERROR CODE F-04-50-04 WAS RECEIVED ALONG WITH THE MESSAGE "P1 PUMP FAILURE." THE MAIN POWER SWITCH WAS FOUND TO BE WORN. THE CUSTOMER WAS PROVIDED WITH PART NUMBERS FOR THE POWER SWITCH AND HARNESS AND ADVISED TO REPLACE THE PARTS. THE RO SYSTEM WAS PLACED IN EMERGENCY MODE STAGE 2 UNTIL THE ARRIVAL AND INSTALLATION OF THE REPLACEMENT PARTS. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP WITH THE BIOMED. THE BIOMED STATED THAT THE REVERSE OSMOSIS (RO) SYSTEM INITIATED A T1 TEST AND IT SHUT OFF DUE TO THE THERMAL DAMAGE SUSTAINED BY THE MOTOR PROTECTION SWITCH (MPS). THE BIOMED INDICATED THAT THERMAL DAMAGE WAS IDENTIFIED ON THE MPS AT THE L3 POINT AND ON THE CABLES/LINES CONNECTING TO IT (INCLUDING L3, L2 ALSO HAD MINOR HEAT DAMAGE, POSSIBLY DUE TO PROXIMITY TO L3). THERE WAS MELTED PLASTIC AS WELL AS DISCOLORATION TO THE LABELS AND PINS. THE BIOMED SUSPECTS THAT A SURGE OF POWER DURING THE T1 TEST RESULTED IN THE IDENTIFIED THERMAL DAMAGE HOWEVER THE BIOMED IS UNSURE HOW TO REPLICATE THE REPORTED ISSUE IN ORDER TO CONFIRM IT. THE BIOMED CONFIRMED THAT THE ERROR CODE F-04-50-04 WAS RECEIVED ALONG WITH THE MESSAGE "FAILURE: T1 TEST, PUMP P1 DEFECTIVE, PUMP DEFECTIVE MOTOR SWITCH HAS TRIPPED." THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THE BIOMED STATED THE THERMAL OVERLOAD RELAY ALSO TRIPPED DURING THE T1 TEST. THERE WERE NO BLOWN FUSES IDENTIFIED IN THE LOCAL POWER SUPPLY. THERE WERE NO LOCAL POWER GRID ISSUES AROUND THE EVENT DATE, NOR WERE ANY STORMS OCCURRING IN THE AREA ON OR AROUND THE REPORTED EVENT DATE. IT WAS CONFIRMED THE MACHINE IS PLUGGED INTO ITS OWN BREAKER. THE BIOMED STATED THAT THE SWITCH AND CABLES HAVE BEEN REPLACED TO RESOLVE THE REPORTED ISSUE. THE MACHINE HAS BEEN RETURNED TO SERVICE. PHOTOGRAPHS OF THE IDENTIFIED THERMAL DAMAGE WAS PROVIDED FOR REVIEW BY THE MANUFACTURER. NO FILES OR SAMPLES WERE REPORTED TO BE AVAILABLE. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY INDIVIDUAL AS A RESULT OF THE REPORTED ISSUE.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5 (EVENT DESCRIPTION - EMERGENCY MODE STAGE 2 FROM STAGE 1) 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 FRESENIUS TECHNICAL SERVICES THAT INDICATIONS OF BURNT OR CHARRED WIRING WAS PRESENT WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE REPORTED ISSUE WAS DISCOVERED DURING TROUBLESHOOTING. THE BIOMED INITIALLY CONTACTED FRESENIUS WITH ASSISTANCE AFTER THE T1 TEST FAILED. ERROR CODE F-04-50-04 WAS RECEIVED ALONG WITH THE MESSAGE "P1 PUMP FAILURE." THE MAIN POWER SWITCH WAS FOUND TO BE WORN. THE CUSTOMER WAS PROVIDED WITH PART NUMBERS FOR THE POWER SWITCH AND HARNESS AND ADVISED TO REPLACE THE PARTS. THE RO SYSTEM WAS PLACED IN EMERGENCY MODE STAGE 2 UNTIL THE ARRIVAL AND INSTALLATION OF THE REPLACEMENT PARTS. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP WITH THE BIOMED. THE BIOMED STATED THAT THE REVERSE OSMOSIS (RO) SYSTEM INITIATED A T1 TEST AND IT SHUT OFF DUE TO THE THERMAL DAMAGE SUSTAINED BY THE MOTOR PROTECTION SWITCH (MPS). THE BIOMED INDICATED THAT THERMAL DAMAGE WAS IDENTIFIED ON THE MPS AT THE L3 POINT AND ON THE CABLES/LINES CONNECTING TO IT (INCLUDING L3, L2 ALSO HAD MINOR HEAT DAMAGE, POSSIBLY DUE TO PROXIMITY TO L3). THERE WAS MELTED PLASTIC AS WELL AS DISCOLORATION TO THE LABELS AND PINS. THE BIOMED SUSPECTS THAT A SURGE OF POWER DURING THE T1 TEST RESULTED IN THE IDENTIFIED THERMAL DAMAGE HOWEVER THE BIOMED IS UNSURE HOW TO REPLICATE THE REPORTED ISSUE IN ORDER TO CONFIRM IT. THE BIOMED CONFIRMED THAT THE ERROR CODE F-04-50-04 WAS RECEIVED ALONG WITH THE MESSAGE "FAILURE: T1 TEST, PUMP P1 DEFECTIVE, PUMP DEFECTIVE MOTOR SWITCH HAS TRIPPED." THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THE BIOMED STATED THE THERMAL OVERLOAD RELAY ALSO TRIPPED DURING THE T1 TEST. THERE WERE NO BLOWN FUSES IDENTIFIED IN THE LOCAL POWER SUPPLY. THERE WERE NO LOCAL POWER GRID ISSUES AROUND THE EVENT DATE, NOR WERE ANY STORMS OCCURRING IN THE AREA ON OR AROUND THE REPORTED EVENT DATE. IT WAS CONFIRMED THE MACHINE IS PLUGGED INTO ITS OWN BREAKER. THE BIOMED STATED THAT THE SWITCH AND CABLES HAVE BEEN REPLACED TO RESOLVE THE REPORTED ISSUE. THE MACHINE HAS BEEN RETURNED TO SERVICE. PHOTOGRAPHS OF THE IDENTIFIED THERMAL DAMAGE WAS PROVIDED FOR REVIEW BY THE MANUFACTURER. NO FILES OR SAMPLES WERE REPORTED TO BE AVAILABLE. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY INDIVIDUAL AS A RESULT OF THE REPORTED ISSUE.

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO SAMPLES WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER THE MANUFACTURER CONFIRMED THE REPORTED EVENT BASED ON THE PROVIDED INFORMATION AND SAMPLE PHOTOGRAPHS. THE COMPLAINT INVESTIGATION DETERMINED THAT THE LIKELY CAUSE OF THE THERMAL DAMAGE WAS A LOOSE ELECTRICAL CONTACT AT THE MOTOR PROTECTION SWITCH. IN SUCH AN INSTANCE THE PUMP WILL RUN ONLY WITH TWO LINE CONDUCTORS, RESULTING IN HIGHER CURRENT AND HIGHER THERMAL ENERGY. THE CABLE LUGS AT THE MOTOR PROTECTION SWITCH CAN GET OVERHEATED AND DISCOLORED BY THE RELEASED THERMAL ENERGY AT THE BAD ELECTRICAL CONTACT. THIS IS A KNOWN FAILURE. CORRECTIVE ACTIONS HAVE BEEN DEFINED AND IMPLEMENTED FOR THIS KNOWN FAILURE. THE WIRING WAS REDESIGNED AND RELEASED. THE DEVICE WAS BUILT BEFORE THE IMPROVEMENT OF THE DESIGN. IN THIS INSTANCE THE SWITCH AND CONNECTED WIRING WERE REPLACED TO RESOLVE THE REPORTED ISSUE. IT IS RECOMMENDED, IF NOT ALREADY DONE, TO REPLACE THE MOTOR PROTECTION SWITCH AND BLACK CONNECTION WIRES AGAINST THE IMPROVED DESIGN IN STAGE 1 AND STAGE 2.

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 FRESENIUS TECHNICAL SERVICES THAT INDICATIONS OF BURNT OR CHARRED WIRING WAS PRESENT WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE REPORTED ISSUE WAS DISCOVERED DURING TROUBLESHOOTING. THE BIOMED INITIALLY CONTACTED FRESENIUS WITH ASSISTANCE AFTER THE T1 TEST FAILED. ERROR CODE F-04-50-04 WAS RECEIVED ALONG WITH THE MESSAGE "P1 PUMP FAILURE." THE MAIN POWER SWITCH WAS FOUND TO BE WORN. THE CUSTOMER WAS PROVIDED WITH PART NUMBERS FOR THE POWER SWITCH AND HARNESS AND ADVISED TO REPLACE THE PARTS. THE RO SYSTEM WAS PLACED IN EMERGENCY MODE STAGE 1 UNTIL THE ARRIVAL AND INSTALLATION OF THE REPLACEMENT PARTS. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP WITH THE BIOMED. THE BIOMED STATED THAT THE REVERSE OSMOSIS (RO) SYSTEM INITIATED A T1 TEST AND IT SHUT OFF DUE TO THE THERMAL DAMAGE SUSTAINED BY THE MOTOR PROTECTION SWITCH (MPS). THE BIOMED INDICATED THAT THERMAL DAMAGE WAS IDENTIFIED ON THE MPS AT THE L3 POINT AND ON THE CABLES/LINES CONNECTING TO IT (INCLUDING L3, L2 ALSO HAD MINOR HEAT DAMAGE, POSSIBLY DUE TO PROXIMITY TO L3). THERE WAS MELTED PLASTIC AS WELL AS DISCOLORATION TO THE LABELS AND PINS. THE BIOMED SUSPECTS THAT A SURGE OF POWER DURING THE T1 TEST RESULTED IN THE IDENTIFIED THERMAL DAMAGE HOWEVER THE BIOMED IS UNSURE HOW TO REPLICATE THE REPORTED ISSUE IN ORDER TO CONFIRM IT. THE BIOMED CONFIRMED THAT THE ERROR CODE F-04-50-04 WAS RECEIVED ALONG WITH THE MESSAGE "FAILURE: T1 TEST, PUMP P1 DEFECTIVE, PUMP DEFECTIVE MOTOR SWITCH HAS TRIPPED." THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THE BIOMED STATED THE THERMAL OVERLOAD RELAY ALSO TRIPPED DURING THE T1 TEST. THERE WERE NO BLOWN FUSES IDENTIFIED IN THE LOCAL POWER SUPPLY. THERE WERE NO LOCAL POWER GRID ISSUES AROUND THE EVENT DATE, NOR WERE ANY STORMS OCCURRING IN THE AREA ON OR AROUND THE REPORTED EVENT DATE. IT WAS CONFIRMED THE MACHINE IS PLUGGED INTO ITS OWN BREAKER. THE BIOMED STATED THAT THE SWITCH AND CABLES HAVE BEEN REPLACED TO RESOLVE THE REPORTED ISSUE. THE MACHINE HAS BEEN RETURNED TO SERVICE. PHOTOGRAPHS OF THE IDENTIFIED THERMAL DAMAGE WAS PROVIDED FOR REVIEW BY THE MANUFACTURER. NO FILES OR SAMPLES WERE REPORTED TO BE AVAILABLE. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY INDIVIDUAL AS A RESULT OF THE REPORTED ISSUE.