AQUABPLUS, B2, HF 2000 KIT

Additional Manufacturer Narrative

PLANT INVESTIGATION: BASED ON THE PROVIDED PHOTOGRAPH AND INFORMATION, THERMAL DAMAGE OF THE WIRING AT THE MOTOR PROTECTION SWITCH CAN BE CONFIRMED. THE MOST LIKELY FAILURE CAUSE OF THE TRIPPED MOTOR PROTECTION SWITCH IS A MISSING LINE CONDUCTOR DURING PUMP START THAT IS CAUSED BY THE BAD ELECTRICAL CONTACT AT THE MOTOR PROTECTION SWITCH. THE DEVICE WILL RUN WITH ONLY TWO LINE CONDUCTORS CAUSING INCREASED CURRENTS ON THE REMAINING LINE CONDUCTORS AND THE MOTOR PROTECTION SWITCH WILL TRIP FROM THE UNBALANCED LOAD. THE THERMAL DAMAGE AT THE WIRING OF THE MOTOR PROTECTION SWITCH IS ALSO CAUSED BY A BAD ELECTRICAL CONTACT OF THE WIRING AT THE MOTOR PROTECTION SWITCH. A REVIEW FOR SIMILAR COMPLAINTS IS NOT REQUIRED IN THIS CASE. THIS FAILURE TYPE IS A KNOWN FAILURE. A CAPA HAS BEEN OPENED TO ADDRESS THE DESIGN FLAW OF THE USED BLADE RECEPTACLES, WHICH RESULTS IN A BAD ELECTRICAL CONTACT AT THE MOTOR PROTECTION SWITCH PINS, RESULTING IN TRANSITION RESISTANCE AND ULTIMATELY HIGH THERMAL ENERGY AT THE BLADE RECEPTACLES. THE DEVICE WAS BUILT BEFORE AN IMPROVED DESIGN OF THE BLADE RECEPTACLES WAS RELEASED. IT IS RECOMMENDED THAT THE MOTOR PROTECTION SWITCH AND CONNECTED WIRING IN STAGES 1 AND 2 BE REPLACED AGAINST THE IMPROVED DESIGN.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DAMAGE WAS IDENTIFIED ON THE STAGE 1 MOTOR PROTECTION SWITCH (MPS) AND HOUSING OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE MPS APPEARED BURNT AND THERE WERE SCORCH MARKS IDENTIFIED ON THE HOUSING. THE REPORTED ISSUE WAS DISCOVERED AT THE BEGINNING OF THE DAY. THE CLINIC STAFF REPORTED TO THE BIOMED THAT THE RO SYSTEM FAILED TO STAY POWERED ON. THERE WAS NO PATIENT INVOLVEMENT REGARDING THIS ISSUE. THE BIOMED CONFIRMED THE REPORTED EVENT DURING FOLLOW-UP AND PROVIDED ADDITIONAL INFORMATION. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING REGARDING THE REPORTED EVENT. NO AUDIO OR VISUAL ALARMS WERE RECEIVED. NO BLOWN FUSES WERE IDENTIFIED. IT WAS CONFIRMED THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. NO POWER ISSUES WERE EXPERIENCED AT THE FACILITY. THE BIOMED REMOVED THE STAGE 2 MPS AND INSTALLED IT INTO STAGE 1 IN ORDER TO RETURN THE RO SYSTEM TO SERVICE. THE SCORCH MARKS ON THE HOUSING WERE ABLE TO BE CLEANED. THE BIOMED ORDERED A REPLACEMENT MPS FOR STAGE 1 AND 2 AS WELL AS ASSOCIATED WIRING HOWEVER THE REPLACEMENT PARTS HAD NOT ARRIVED AT THE TIME OF FOLLOW-UP. THE RO SYSTEM REMAINS OPERATING IN EMERGENCY MODE UNTIL THE REPLACEMENT PARTS ARRIVE AND CAN BE INSTALLED. THE BIOMED STATED THE SAMPLES ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

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 THERMAL DAMAGE WAS IDENTIFIED ON THE STAGE 1 MOTOR PROTECTION SWITCH (MPS) AND HOUSING OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE MPS APPEARED BURNT AND THERE WERE SCORCH MARKS IDENTIFIED ON THE HOUSING. THE REPORTED ISSUE WAS DISCOVERED AT THE BEGINNING OF THE DAY. THE CLINIC STAFF REPORTED TO THE BIOMED THAT THE RO SYSTEM FAILED TO STAY POWERED ON. THERE WAS NO PATIENT INVOLVEMENT REGARDING THIS ISSUE. THE BIOMED CONFIRMED THE REPORTED EVENT DURING FOLLOW-UP AND PROVIDED ADDITIONAL INFORMATION. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING REGARDING THE REPORTED EVENT. NO AUDIO OR VISUAL ALARMS WERE RECEIVED. NO BLOWN FUSES WERE IDENTIFIED. IT WAS CONFIRMED THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. NO POWER ISSUES WERE EXPERIENCED AT THE FACILITY. THE BIOMED REMOVED THE STAGE 2 MPS AND INSTALLED IT INTO STAGE 1 IN ORDER TO RETURN THE RO SYSTEM TO SERVICE. THE SCORCH MARKS ON THE HOUSING WERE ABLE TO BE CLEANED. THE BIOMED ORDERED A REPLACEMENT MPS FOR STAGE 1 AND 2 AS WELL AS ASSOCIATED WIRING HOWEVER THE REPLACEMENT PARTS HAD NOT ARRIVED AT THE TIME OF FOLLOW-UP. THE RO SYSTEM REMAINS OPERATING IN EMERGENCY MODE UNTIL THE REPLACEMENT PARTS ARRIVE AND CAN BE INSTALLED. THE BIOMED STATED THE SAMPLES ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.