AQUABPLUS 2500 B2 2000

Additional Manufacturer Narrative

PLANT INVESTIGATION: THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION, AND NO PHOTOGRAPHS OF THE REPORTED ISSUE WERE PROVIDED FOR REVIEW. THE REPORTED EVENT WAS CONFIRMED BY MEANS OF THE PROVIDED COMPLAINT INTAKE INFORMATION. THE CAUSE FOR THE FAILURE HAS BEEN DETERMINED TO BE THE RESULT OF AN INADEQUATE DESIGN OF THE CABLE LUGS, WHICH RESULTED IN BAD ELECTRICAL CONTACTING. HIGHER CURRENT EXPOSES THE WIRES AND CABLE LUGS TO HIGHER TEMPERATURES, RESULTING IN THE IDENTIFIED THERMAL DAMAGE. THE REPORTED FAILURE IS A KNOWN ISSUE. CORRECTIVE ACTIONS HAVE BEEN DEFINED AND IMPLEMENTED. AN IMPROVEMENT WAS MADE TO THE DESIGN OF THE ELECTRICAL CONNECTION ON THE MAIN DEVICE SWITCH AND RELEASED TO THE US MARKET. ACCORDING TO THE AVAILABLE INFORMATION, THE WIRING AND THE MOTOR PROTECTION SWITCH WERE REPLACED TO SOLVE THE ISSUE. THE DEVICE HISTORY RECORD (DHR) RELATED DOCUMENTATION HAS BEEN REVIEWED. THE DEVICE HAS BEEN FOUND TO BE CONFORMING TO THE SPECIFICATIONS AND HAS BEEN RELEASED WITHOUT ANY DISCREPANCIES.

Description of Event or Problem

AN ON-CALL BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE AQUAB PLUS REVERSE OSMOSIS (RO) SYSTEM WOULD NOT ENTER STAGE 2 EMERGENCY MODE. THE BIOMED ATTEMPTED TO PLACE THE RO SYSTEM INTO EMERGENCY MODE DUE TO AN UNSPECIFIED POWER ISSUE WHICH HAD RESOLVED. THE RO SYSTEM WAS RUNNING IN SUPPLY MODE AT THE TIME OF THE CALL AND NOT EXPERIENCING ANY ISSUES. THE FACILITY BIOMED STATED DURING FOLLOW-UP THAT THE RO SYSTEM WAS EVALUATED AND THERMAL DECOMPOSITION WAS IDENTIFIED. THE ELECTRICAL CONNECTION FROM THE MOTOR PROTECTION SWITCH (MPS) TO THE AQUAB WAS BURNED. THE CAUSE WAS DETERMINED TO BE A LOOSE CONNECTION WHICH ALSO RESULTED IN ARCING. NO SMOKE, SPARK, OR FLAME OCCURRED. THE WIRE CONNECTION WAS REPLACED, IT WAS VERIFIED THAT THE SYSTEM WAS STILL NOT WORKING, AND THE MPS WAS REPLACED AS WELL, WHICH RESOLVED THE MACHINE ISSUE. THE RO SYSTEM WAS RETURNED TO SERVICE. NO PARTS WILL BE RETURNED TO THE MANUFACTURER. NO PHOTOGRAPHS ARE AVAILABLE FOR REVIEW. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THIS MALFUNCTION.

Description of Event or Problem

AN ON-CALL BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE AQUAB PLUS REVERSE OSMOSIS (RO) SYSTEM WOULD NOT ENTER STAGE 2 EMERGENCY MODE. THE BIOMED ATTEMPTED TO PLACE THE RO SYSTEM INTO EMERGENCY MODE DUE TO AN UNSPECIFIED POWER ISSUE WHICH HAD RESOLVED. THE RO SYSTEM WAS RUNNING IN SUPPLY MODE AT THE TIME OF THE CALL AND NOT EXPERIENCING ANY ISSUES. THE FACILITY BIOMED STATED DURING FOLLOW-UP THAT THE RO SYSTEM WAS EVALUATED AND THERMAL DECOMPOSITION WAS IDENTIFIED. THE ELECTRICAL CONNECTION FROM THE MOTOR PROTECTION SWITCH (MPS) TO THE AQUAB WAS BURNED. THE CAUSE WAS DETERMINED TO BE A LOOSE CONNECTION WHICH ALSO RESULTED IN ARCING. NO SMOKE, SPARK, OR FLAME OCCURRED. THE WIRE CONNECTION WAS REPLACED, IT WAS VERIFIED THAT THE SYSTEM WAS STILL NOT WORKING, AND THE MPS WAS REPLACED AS WELL, WHICH RESOLVED THE MACHINE ISSUE. THE RO SYSTEM WAS RETURNED TO SERVICE. NO PARTS WILL BE RETURNED TO THE MANUFACTURER. NO PHOTOGRAPHS ARE AVAILABLE FOR REVIEW. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THIS MALFUNCTION.

Additional Manufacturer Narrative

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