AQUABPLUS, B2, HF 1000 KIT

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 THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM IS UNEXPECTEDLY POWERING DOWN. TURNING THE POWER BUTTON OFF AND BACK ON TEMPORARILY RESOLVES THE ISSUE. THE BIOMED WAS ADVISED TO CHECK FOR LOOSE WIRES ON THE POWER SWITCH AND TO REPLACE THE POWER SWITCH (P/N# (B)(6)) WHEN TREATMENTS ARE COMPLETED. UPON INITIAL FOLLOW-UP THE BIOMED REPORTED THAT THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN THE RO SYSTEM UPON EVALUATION. THE WIRE CONNECTIONS ON THE POWER SWITCH WERE BROWN. THE POWER SWITCH AND WIRES WERE REPLACED TO RESOLVE THE REPORTED ISSUE. NO OTHER ISSUES WERE IDENTIFIED. THE RO SYSTEM WAS RETURNED TO SERVICE. THERE WAS NO REPORTED HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. PATIENTS WERE ABLE TO COMPLETE TREATMENT DESPITE THE REPORTED EVENT. NO PARTS ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. NO PHOTOGRAPHS ARE AVAILABLE FOR REVIEW.

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND PHOTOGRAPHS WERE NOT PROVIDED FOR REVIEW. HOWEVER, THE MANUFACTURER CONFIRMED THE REPORTED EVENT BASED ON THE PROVIDED INFORMATION. THE REPORTED THERMAL DAMAGE WAS FOUND DURING TROUBLESHOOTING THE INITIAL FAILURE OF UNEXPECTEDLY POWERING DOWN. ACCORDING TO THE INTAKE INFORMATION, THE ISSUE UNEXPECTEDLY POWERING DOWN WAS MOST LIKELY CAUSED BY A BAD ELECTRICAL CONTACT. DUE TO THE BAD ELECTRICAL CONTACT, THE THERMAL OVERLOAD SWITCH AND/OR THE MOTOR PROTECTION SWITCH BECOMES UNBALANCED. IN USE, THE THERMAL OVERLOAD SWITCH WILL TRIP AND INTERRUPT OPERATION. IN THIS CASE, THE DEVICE WAS LIKELY IN A RUNNING T1-TEST AND DUE TO THE BAD ELECTRICAL CONTACT, THE MOTOR PROTECTION SWITCH IN STAGE 1 BECAME UNBALANCED AND TRIPPED AS INTENDED. THE DEVICE THEN SWITCHES IMMEDIATELY OFF WITH NO FAILURE MESSAGE LOGGED. DURING TROUBLESHOOTING, THERMAL DAMAGE AT THE MOTOR PROTECTION SWITCH IN STAGE 1 WAS DETERMINED. THE MOST LIKELY FAILURE CAUSE FOR THE DETERMINED THERMAL DAMAGE WAS 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. THE CABLE LUGS AT THE MOTOR PROTECTION SWITCH OVERHEATED AND DISCOLORED FROM THE RELEASED THERMAL ENERGY, RESULTING IN THE MOTOR PROTECTION SWITCH TRIPPING AND INTERRUPTING DEVICE OPERATION. THIS EVENT REPRESENTS A KNOWN FAILURE. CORRECTIVE ACTIONS WERE DEFINED AND IMPLEMENT. A NEW WIRING DESIGN WAS DEVELOPED AND RELEASED. THE DEVICE WAS BUILT BEFORE IMPROVEMENT OF THE WIRING DESIGN; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD (DHR) IS NOT WARRANTED. ACCORDING TO THE INTAKE INFORMATION THE MOTOR PROTECTION SWITCH AND THE WIRING WERE REPLACED TO SOLVE THE ISSUE. IT IS RECOMMENDED TO REPLACE THE WIRING AND THE MOTOR PROTECTION SWITCH IN STAGE 1 AND STAGE 2 TO PREVENT ADDITIONAL FAILURES.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM IS UNEXPECTEDLY POWERING DOWN. TURNING THE POWER BUTTON OFF AND BACK ON TEMPORARILY RESOLVES THE ISSUE. THE BIOMED WAS ADVISED TO CHECK FOR LOOSE WIRES ON THE POWER SWITCH AND TO REPLACE THE POWER SWITCH (P/N# F50005352) WHEN TREATMENTS ARE COMPLETED. UPON INITIAL FOLLOW-UP THE BIOMED REPORTED THAT THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN THE RO SYSTEM UPON EVALUATION. THE WIRE CONNECTIONS ON THE POWER SWITCH WERE BROWN. THE POWER SWITCH AND WIRES WERE REPLACED TO RESOLVE THE REPORTED ISSUE. NO OTHER ISSUES WERE IDENTIFIED. THE RO SYSTEM WAS RETURNED TO SERVICE. THERE WAS NO REPORTED HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. PATIENTS WERE ABLE TO COMPLETE TREATMENT DESPITE THE REPORTED EVENT. NO PARTS ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. NO PHOTOGRAPHS ARE AVAILABLE FOR REVIEW.