AQUABPLUS, B2, HF 2000 KIT

Additional Manufacturer Narrative

CORRECTION: H6 (INVESTIGATION CONCLUSIONS).

Description of Event or Problem

THE BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE RO SYSTEM INITIALLY LOST POWER. NO MESSAGES OR ALARMS WERE RECEIVED. UPON EVALUATION THE BLACK WIRES FROM THE MOTOR PROTECTION SWITCH (MPS) WERE FOUND TO BE BURNED AT THE MOTOR CONTACTOR. THE BIOMED WAS ADVISED BY FRESENIUS TO SWAP THE MOTOR CONTACTOR AND CABLE FROM STAGE 2 AND RUN THE RO SYSTEM IN EMERGENCY MODE STAGE 1. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME OR ARCING. A BLOWN 30A FUSE WAS ALSO DISCOVERED WITHIN THE EXTERNAL SERVICE DISCONNECT. THE THERMAL OVERLOAD RELAY DID NOT TRIP AND THERE WERE NO LOCAL POWER GRID ISSUES OR STORMS IN THE AREA ON OR AROUND THE REPORTED EVENT DATE. THE CONTACTOR WAS REPLACED TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS RETURNED TO SERVICE FOLLOWING REPAIR. NO PARTS ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION.

Additional Manufacturer Narrative

PLANT INVESTIGATION: THE REPORTED EVENT WAS CONFIRMED BY THE MANUFACTURER FROM THE PROVIDED INTAKE INFORMATION. THE IDENTIFIED THERMAL DAMAGE WAS MOST LIKELY CAUSED BY A BAD ELECTRICAL CONTACT AT THE MOTOR PROTECTION SWITCH. THE CONTACT RESISTANCE INCREASED AND THE PUMP CURRENT LED TO INCREASED THERMAL ENERGY AT THE CONTACTS POINTS. THE CABLE LUGS/WIRING AT THE MOTOR PROTECTION SWITCH OVERHEATED AND DISCOLORED/DAMAGED FROM THE RELEASED THERMAL ENERGY AT THE BAD ELECTRICAL CONTACT. THIS FAILURE IS A KNOWN ISSUE. CORRECTIVE ACTIONS WERE DEFINED AND IN THE PROCESS OF IMPLEMENTATION. A NEW WIRING DESIGN FOR THE SWITCH WAS RELEASED BUT AT THE TIME OF THIS EVENT WAS NOT AVAILABLE FOR THE US MARKET. THE ISSUE WAS TEMPORARILY SOLVED BY REPLACING THE WIRING AND THE MOTOR PROTECTION SWITCH WITH THE PARTS FROM STAGE 2. IT IS RECOMMENDED, IF NOT ALREADY DONE, TO REPLACE THE WIRING AND THE MOTOR PROTECTION SWITCH IN STAGE 1 AND STAGE 2. A DEVICE HISTORY RECORD (DHR) REVIEW IS NOT REQUIRED AS THE AFFECTED AQUABPLUS WAS MANUFACTURED BEFORE THE CORRECTIVE ACTION WAS IMPLEMENTED INTO SERIES PRODUCTION.

Description of Event or Problem

THE BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE RO SYSTEM INITIALLY LOST POWER. NO MESSAGES OR ALARMS WERE RECEIVED. UPON EVALUATION THE BLACK WIRES FROM THE MOTOR PROTECTION SWITCH (MPS) WERE FOUND TO BE BURNED AT THE MOTOR CONTACTOR. THE BIOMED WAS ADVISED BY FRESENIUS TO SWAP THE MOTOR CONTACTOR AND CABLE FROM STAGE 2 AND RUN THE RO SYSTEM IN EMERGENCY MODE STAGE 1. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME OR ARCING. A BLOWN 30A FUSE WAS ALSO DISCOVERED WITHIN THE EXTERNAL SERVICE DISCONNECT. THE THERMAL OVERLOAD RELAY DID NOT TRIP AND THERE WERE NO LOCAL POWER GRID ISSUES OR STORMS IN THE AREA ON OR AROUND THE REPORTED EVENT DATE. THE CONTACTOR WAS REPLACED TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS RETURNED TO SERVICE FOLLOWING REPAIR. NO PARTS ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION.

Description of Event or Problem

THE BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE RO SYSTEM INITIALLY LOST POWER. NO MESSAGES OR ALARMS WERE RECEIVED. UPON EVALUATION THE BLACK WIRES FROM THE MOTOR PROTECTION SWITCH (MPS) WERE FOUND TO BE BURNED AT THE MOTOR CONTACTOR. THE BIOMED WAS ADVISED BY FRESENIUS TO SWAP THE MOTOR CONTACTOR AND CABLE FROM STAGE 2 AND RUN THE RO SYSTEM IN EMERGENCY MODE STAGE 1. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME OR ARCING. A BLOWN 30A FUSE WAS ALSO DISCOVERED WITHIN THE EXTERNAL SERVICE DISCONNECT. THE THERMAL OVERLOAD RELAY DID NOT TRIP AND THERE WERE NO LOCAL POWER GRID ISSUES OR STORMS IN THE AREA ON OR AROUND THE REPORTED EVENT DATE. THE CONTACTOR WAS REPLACED TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS RETURNED TO SERVICE FOLLOWING REPAIR. NO PARTS ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION.

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

THE BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE RO SYSTEM INITIALLY LOST POWER. NO MESSAGES OR ALARMS WERE RECEIVED. UPON EVALUATION THE BLACK WIRES FROM THE MOTOR PROTECTION SWITCH (MPS) WERE FOUND TO BE BURNED AT THE MOTOR CONTACTOR. THE BIOMED WAS ADVISED BY FRESENIUS TO SWAP THE MOTOR CONTACTOR AND CABLE FROM STAGE 2 AND RUN THE RO SYSTEM IN EMERGENCY MODE STAGE 1. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER A RESPONSE WAS NOT RECEIVED. A SAMPLE WAS NOT REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO REPORT HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION.

Additional Manufacturer Narrative

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