AQUABPLUS, B2, HF 2000 KIT

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE TEMPERATURE SENSOR ON THE BOOSTER PUMP CAME OFF AND SPRAYED PRE-TREATMENT WATER ON THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM AND THE ELECTRICAL WALL PANEL. EVERYTHING WAS WET. WATER WAS PRESENT INSIDE THE PANELS. THE RO SYSTEM WAS POWERED OFF AND THE PATIENTS WERE SENT HOME. THERE WERE NO DIAGNOSTIC MESSAGES OR AUDIBLE ALARMS. FOLLOWING THE EVENT THE RO SYSTEM WOULD RUN FOR ABOUT 10 TO 15 MINUTES THEN TRIP THE STAGE 1 MOTOR PROTECTION SWITCH. DURING EVALUATION THE BIOMED VISUALLY CONFIRMED THAT THE WIRES ON THE BACK OF THE MOTOR PROTECTION SWITCH HAD SUSTAINED THERMAL DAMAGE. IT WAS SPECIFIED THAT THESE WIRES ARE CONNECTED TO THE POWER DISTRIBUTION BOX. THE WIRES WERE GETTING HOT AND SHOWING SIGNS OF HEAT (VIA DISCOLORATION). THE MOTOR PROTECTION SWITCH WAS REPLACED. THE BIOMED WAS ADVISED TO LEAVE THE RO SYSTEM POWERED DOWN UNTIL EVERYTHING COULD DRY AND AN ELECTRICIAN COULD COME ONSITE TO CHECK THE INCOMING POWER. THE BIOMED WAS ALSO ADVISED TO REPLACE THE POWER CABLES (AND PART NUMBER F500005232 WAS PROVIDED FOR THE POWER CORD). ADDITIONAL INFORMATION WAS REQUESTED HOWEVER A RESPONSE WAS NOT RECEIVED. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO REPORTED HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5 (EVENT DESCRIPTION) 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 THE TEMPERATURE SENSOR ON THE BOOSTER PUMP CAME OFF AND SPRAYED PRE-TREATMENT WATER ON THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM AND THE ELECTRICAL WALL PANEL. EVERYTHING WAS WET. WATER WAS PRESENT INSIDE THE PANELS. THE RO SYSTEM WAS POWERED OFF AND THE PATIENTS WERE SENT HOME. THERE WERE NO DIAGNOSTIC MESSAGES OR AUDIBLE ALARMS. FOLLOWING THE EVENT THE RO SYSTEM WOULD RUN FOR ABOUT 10 TO 15 MINUTES THEN TRIP THE STAGE 1 MOTOR PROTECTION SWITCH. DURING EVALUATION THE BIOMED VISUALLY CONFIRMED THAT THE WIRES ON THE BACK OF THE MOTOR PROTECTION SWITCH HAD SUSTAINED THERMAL DAMAGE. IT WAS SPECIFIED THAT THESE WIRES ARE CONNECTED TO THE POWER DISTRIBUTION BOX. THE WIRES WERE GETTING HOT AND SHOWING SIGNS OF HEAT (VIA DISCOLORATION). THE MOTOR PROTECTION SWITCH WAS REPLACED. THE BIOMED WAS ADVISED TO LEAVE THE RO SYSTEM POWERED DOWN UNTIL EVERYTHING COULD DRY AND AN ELECTRICIAN COULD COME ONSITE TO CHECK THE INCOMING POWER. THE BIOMED WAS ALSO ADVISED TO REPLACE THE POWER CABLES (AND PART NUMBER F500005232 WAS PROVIDED FOR THE POWER CORD). ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP WITH THE BIOMED. NO BLOWN FUSES WERE IDENTIFIED. THERE WERE NO RECENT POWER GRID ISSUES OR ELECTRICAL STORMS. IT WAS NOTED THAT THE THERMAL OVERLOAD RELAY TRIPPED IN SUPPLY MODE AFTER THE T1 TEST. THE POWER CABLE WITH CONNECTORS AS WELL AS THE SWITCH WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM HAS BEEN RETURNED TO SERVICE. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO REPORTED HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE TEMPERATURE SENSOR ON THE BOOSTER PUMP CAME OFF AND SPRAYED PRE-TREATMENT WATER ON THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM AND THE ELECTRICAL WALL PANEL. EVERYTHING WAS WET. WATER WAS PRESENT INSIDE THE PANELS. THE RO SYSTEM WAS POWERED OFF AND THE PATIENTS WERE SENT HOME. THERE WERE NO DIAGNOSTIC MESSAGES OR AUDIBLE ALARMS. FOLLOWING THE EVENT THE RO SYSTEM WOULD RUN FOR ABOUT 10 TO 15 MINUTES THEN TRIP THE STAGE 1 MOTOR PROTECTION SWITCH. DURING EVALUATION THE BIOMED VISUALLY CONFIRMED THAT THE WIRES ON THE BACK OF THE MOTOR PROTECTION SWITCH HAD SUSTAINED THERMAL DAMAGE. IT WAS SPECIFIED THAT THESE WIRES ARE CONNECTED TO THE POWER DISTRIBUTION BOX. THE WIRES WERE GETTING HOT AND SHOWING SIGNS OF HEAT (VIA DISCOLORATION). THE MOTOR PROTECTION SWITCH WAS REPLACED. THE BIOMED WAS ADVISED TO LEAVE THE RO SYSTEM POWERED DOWN UNTIL EVERYTHING COULD DRY AND AN ELECTRICIAN COULD COME ONSITE TO CHECK THE INCOMING POWER. THE BIOMED WAS ALSO ADVISED TO REPLACE THE POWER CABLES (AND PART NUMBER F500005232 WAS PROVIDED FOR THE POWER CORD). ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP WITH THE BIOMED. NO BLOWN FUSES WERE IDENTIFIED. THERE WERE NO RECENT POWER GRID ISSUES OR ELECTRICAL STORMS. IT WAS NOTED THAT THE THERMAL OVERLOAD RELAY TRIPPED IN SUPPLY MODE AFTER THE T1 TEST. THE POWER CABLE WITH CONNECTORS AS WELL AS THE SWITCH WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM HAS BEEN RETURNED TO SERVICE. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO REPORTED HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE.

Additional Manufacturer Narrative

PLANT INVESTIGATION: PHOTOGRAPHS AND VIDEO WERE PROVIDED TO THE MANUFACTURER FOR REVIEW WHICH WERE USED ALONG WITH THE INTAKE INFORMATION TO CONFIRM THE REPORTED ISSUE. THE THERMAL DAMAGE OCCURRED DUE A BAD ELECTRICAL CONNECTION THAT RESULTED IN HIGH CONTACT RESISTANCE AND THERMAL POWER LOSS. AS HIGHER CURRENTS, THE CONCERNED COMPONENTS ARE EXPOSED TO HIGHER TEMPERATURES RESPECTIVELY, RESULTING IN THE FOUND THERMAL DAMAGE. THE REPORTED FAILURE PATTERN IS A KNOWN ISSUE. CORRECTIVE ACTIONS HAVE BEEN DEFINED AND IMPLEMENTED. A NEW CRIMP CONNECTION WAS REDESIGNED. THIS DESIGN WAS RELEASED AFTER THE MANUFACTURE FOR THIS DEVICE. ACCORDING THE COMPLAINT INTAKE INFORMATION THE MOTOR PROTECTION SWITCH AND THE POWER CORD WAS REPLACED. IT IS RECOMMENDED TO REPLACE THE MOTOR PROTECTION SWITCH AND WIRING ATTACHED TO THE MOTOR PROTECTION SWITCH IN BOTH STAGES TO AVOID ADDITIONAL FAILURES.