AQUABPLUS, B2, HF 2000 KIT

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DECOMPOSITION WAS DISCOVERED IN STAGE 1 OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE WIRING CONNECTED TO THE MOTOR PROTECTION SWITCH (MPS) WAS CHARRED. THE REPORTED ISSUE WAS DISCOVERED DURING TROUBLESHOOTING FOR ERROR CODE ¿ F¿04¿51¿04 FAILURE: T1 TEST, PUMP P1S DEFECTIVE¿ WHICH WAS ENCOUNTERED DURING THE T1 TEST. THERE WAS NO OBSERVED SMOKE, SPARK, FLAME, OR ARCING, HOWEVER A BURNING SMELL WAS NOTED UPON REMOVING THE STAGE 1 HOOD. THERE WERE NO BLOWN FUSES, NO TRIPPED SWITCHES, AND NO REPORTED LOCAL POWER GRID ISSUES OR ELECTRICAL STORMS ON OR AROUND THE REPORTED EVENT DATE. REPLACEMENT PARTS WERE ORDERED. FRESENIUS ASSISTED THE BIOMED WITH PLACING THE RO SYSTEM INTO EMERGENCY MODE 1 UNTIL REPAIRS COULD BE COMPLETED. UPON FOLLOW-UP THE BIOMED CONFIRMED THAT THE SWITCH AND CONNECTED WIRING HAD BEEN REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM HAD BEEN RETURNED TO SERVICE. NO PHOTOGRAPH OR SAMPLE WAS AVAILABLE FOR REVIEW. THE BIOMED CONFIRMED THAT THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION.

Additional Manufacturer Narrative

PLANT INVESTIGATION: THE MANUFACTURER CONFIRMED THE REPORTED EVENT FROM THE PROVIDED INTAKE INFORMATION. THE CAUSE FOR THE IDENTIFIED THERMAL DAMAGE IS DETERMINED TO BE A BAD ELECTRICAL CONTACT AT THE MOTOR PROTECTION SWITCH. THE CONTACT RESISTANCE AND PUMP CURRENT INCREASED WHICH LED TO INCREASED THERMAL ENERGY AT THE CONTACTS POINTS WHICH OVERHEATED AND DAMAGED/DISCOLORED THE BAD ELECTRICAL CONTACT. DEVICE OPERATION WAS THEN INTERRUPTED. THIS FAILURE IS A KNOWN ISSUE. CORRECTIVE ACTIONS WERE DEFINED AND ARE UNDER IMPLEMENTATION A NEW DESIGN OF THE MOTOR PROTECTION SWITCH AND ITS WIRING IS DEVELOPED, BUT NOT RELEASED FOR THE US MARKET AT THE TIME OF THE EVENT. ACCORDING TO THE INTAKE INFORMATION, THE WIRING AND THE MOTOR PROTECTION SWITCH IN STAGE 1 WERE REPLACED TO RESOLVE THE THERMAL DAMAGE. IT IS RECOMMENDED TO REPLACE ALSO THE WIRING AND THE MOTOR PROTECTION SWITCH IN STAGE 2 TO AVOID ADDITIONAL FAILURES.

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 DECOMPOSITION WAS DISCOVERED IN STAGE 1 OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE WIRING CONNECTED TO THE MOTOR PROTECTION SWITCH (MPS) WAS CHARRED. THE REPORTED ISSUE WAS DISCOVERED DURING TROUBLESHOOTING FOR ERROR CODE ¿F¿04¿51¿04 FAILURE: T1 TEST, PUMP P1S DEFECTIVE¿ WHICH WAS ENCOUNTERED DURING THE T1 TEST. THERE WAS NO OBSERVED SMOKE, SPARK, FLAME, OR ARCING, HOWEVER A BURNING SMELL WAS NOTED UPON REMOVING THE STAGE 1 HOOD. THERE WERE NO BLOWN FUSES, NO TRIPPED SWITCHES, AND NO REPORTED LOCAL POWER GRID ISSUES OR ELECTRICAL STORMS ON OR AROUND THE REPORTED EVENT DATE. REPLACEMENT PARTS WERE ORDERED. FRESENIUS ASSISTED THE BIOMED WITH PLACING THE RO SYSTEM INTO EMERGENCY MODE 1 UNTIL REPAIRS COULD BE COMPLETED. UPON FOLLOW-UP THE BIOMED CONFIRMED THAT THE SWITCH AND CONNECTED WIRING HAD BEEN REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM HAD BEEN RETURNED TO SERVICE. NO PHOTOGRAPH OR SAMPLE WAS AVAILABLE FOR REVIEW. THE BIOMED CONFIRMED THAT THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION.