AQUABPLUS, B2, HF 2000 KIT

Description of Event or Problem

AN ON-CALL BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE SCREEN OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM WAS BLANK. UPON EVALUATION, THERMAL DECOMPOSITION WAS IDENTIFIED ON THE WIRES CONNECTED TO THE MOTOR PROTECTION SWITCH (MPS). THE RO SYSTEM WAS PLACED INTO EMERGENCY MODE STAGE 2. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP WITH THE BIOMED. THE MOTOR PROTECTION SWITCH (MPS) FOR BOTH STAGE 1 AND STAGE 2 WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM SUSTAINED THERMAL DAMAGE. THE BACKSIDE OF THE SWITCHES WHERE THE PINS ARE LOCATED WERE BLACKENED. BUBBLING PLASTIC WAS ALSO NOTED ON THE STAGE 1 MPS. A BURNING SMELL WAS NOTED HOWEVER THERE WAS NO OBSERVED SMOKE, SPARK, FLAME, OR ARCING. THE REPORTED ISSUE WAS DISCOVERED DURING EVALUATION AFTER THE RO LOST POWER JUST PRIOR TO STARTING TREATMENTS FOR THE DAY. THERE WERE NO BLOWN FUSES IDENTIFIED. THE THERMAL OVERLOAD RELAY DID NOT TRIP. IT WAS CONFIRMED THAT ELECTRICAL STORMS HAD OCCURRED IN THE AREA AROUND THE TIME OF THE REPORTED EVENT. THE STAGE 1 MPS WAS REPLACED. THE RO SYSTEM WAS PLACED INTO EMERGENCY MODE STAGE 2 TO BE RETURNED TO SERVICE. A REPLACEMENT WIRING HARNESS AND MPS WERE ORDERED. THE PARTS WILL BE REPLACED UPON ARRIVAL IN ORDER TO RESTORE THE RO SYSTEM TO FULL OPERATION. PHOTOGRAPHS AVAILABLE TO BE OBTAINED FOR REVIEW. NO SAMPLES ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL 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

PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER THE MANUFACTURER CONFIRMED THE REPORTED ISSUE BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER. THE MANUFACTURER DETERMINED THAT THE THERMAL DAMAGE OCCURRED DUE TO HIGH CONTACT RESISTANCE AND THERMAL POWER LOSS AT AS THE RESULT OF POOR ELECTRICAL CONTACT AT THE MOTOR PROTECTION SWITCH. THE HIGH CURRENTS RESULTED IN THERMAL DAMAGE TO THE THE WIRES AND CABLE LUGS. THIS IS A KNOWN FAILURE. CORRECTIVE ACTIONS HAVE BEEN DEFINED AND IMPLEMENTED. THE CRIMPED CABLE LUG HAS BEEN RE-DESIGNED. THE RE-DESIGNED PART IS CURRENTLY NOT RELEASED FOR THE US MARKET. ACCORDING TO THE AVAILABLE INFORMATION, THE MOTOR PROTECTION SWITCH STAGE 1 WAS REPLACED TO RESOLVE THE ISSUE. IT IS RECOMMENDED TO REPLACE THE MOTOR PROTECTION SWITCH STAGE 2 AND THE COMPLETE WIRING ATTACHED TO THE MOTOR PROTECTION SWITCHES STAGE 1 AND STAGE 2.

Description of Event or Problem

AN ON-CALL BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE SCREEN OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM WAS BLANK. UPON EVALUATION, THERMAL DECOMPOSITION WAS IDENTIFIED ON THE WIRES CONNECTED TO THE MOTOR PROTECTION SWITCH (MPS). THE RO SYSTEM WAS PLACED INTO EMERGENCY MODE STAGE 2. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP WITH THE BIOMED. THE MOTOR PROTECTION SWITCH (MPS) FOR BOTH STAGE 1 AND STAGE 2 WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM SUSTAINED THERMAL DAMAGE. THE BACKSIDE OF THE SWITCHES WHERE THE PINS ARE LOCATED WERE BLACKENED. BUBBLING PLASTIC WAS ALSO NOTED ON THE STAGE 1 MPS. A BURNING SMELL WAS NOTED HOWEVER THERE WAS NO OBSERVED SMOKE, SPARK, FLAME, OR ARCING. THE REPORTED ISSUE WAS DISCOVERED DURING EVALUATION AFTER THE RO LOST POWER JUST PRIOR TO STARTING TREATMENTS FOR THE DAY. THERE WERE NO BLOWN FUSES IDENTIFIED. THE THERMAL OVERLOAD RELAY DID NOT TRIP. IT WAS CONFIRMED THAT ELECTRICAL STORMS HAD OCCURRED IN THE AREA AROUND THE TIME OF THE REPORTED EVENT. THE STAGE 1 MPS WAS REPLACED. THE RO SYSTEM WAS PLACED INTO EMERGENCY MODE STAGE 2 TO BE RETURNED TO SERVICE. A REPLACEMENT WIRING HARNESS AND MPS WERE ORDERED. THE PARTS WILL BE REPLACED UPON ARRIVAL IN ORDER TO RESTORE THE RO SYSTEM TO FULL OPERATION. PHOTOGRAPHS AVAILABLE TO BE OBTAINED FOR REVIEW. NO SAMPLES ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE.