AQUABPLUS, B2, HF 2000 KIT

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO SAMPLE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER, THE REPORTED EVENT WAS CONFIRMED WITH THE PROVIDED PHOTOGRAPHS. THE THERMAL DAMAGE WAS CAUSED BY A BAD ELECTRICAL CONTACT AT THE MOTOR PROTECTION SWITCH. THE CONTACT RESISTANCE AND PUMP CURRENT INCREASED AND LED TO AN INCREASED THERMAL ENERGY AT THE CONTACTS POINTS. THE CABLE LUGS/WIRING AT THE MOTOR PROTECTION SWITCH OVERHEATED AND BECAME DISCOLORED/DAMAGED BY THE RELEASED THERMAL ENERGY AT THE BAD ELECTRICAL CONTACT. DUE TO THE BAD ELECTRICAL CONTACT A MAINS LINE COULD BE MISSING AND THE THERMAL OVERLOAD SWITCH OR THE MOTOR PROTECTION SWITCH (DEPENDING ON THE OPERATION MODE) IS LOADED UNBALANCED AND COULD TRIP. AS A CONSEQUENCE, THE DEVICE OPERATION COULD BE INTERRUPTED. IN THIS CASE ERROR CODE F-04-50-04 WAS REPORTED. REGARDLESS OF THE CAUSE OF THIS COMPLAINT, A DESIGN CHANGE FOR A DIFFERENT MOTOR PROTECTION SWITCH TYPE AND ELECTRICAL CONNECTION WAS SUBMITTED. THE NEW DESIGN IS CURRENTLY NOT AVAILABLE FOR THE US MARKET. ACCORDING TO THE INTAKE INFORMATION, THE MOTOR PROTECTION SWITCH, THE WIRING AND THE CONTACTOR WERE REPLACED TO SOLVE THE ISSUE. FURTHERMORE, IT IS RECOMMENDED, IF NOT ALREADY DONE, TO REPLACE THE WIRING AND THE MOTOR PROTECTION SWITCH IN STAGE 2.

Description of Event or Problem

THE BIOMEDICAL TECHNICIAN (BIOMED) FOR A USER FACILITY REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE REPORTED ISSUE WAS DISCOVERED DURING TROUBLESHOOTING AFTER THE RO SYSTEM ALARMED DURING THE T1 TEST WITH ERROR "F-04-50-04 T1 TEST. PUMP P1 DEFECTIVE." THE BIOMED WAS ADVISED TO PLACE THE RO SYSTEM IN EMERGENCY MODE. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THE MOTOR PROTECTION SWITCH (MPS) AND CONNECTED WIRING SUSTAINED THERMAL DAMAGE. THE PARTS APPEARED BLACKENED AND CHARRED. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. THE ERROR LOG INCLUDED THE FOLLOWING ENTRY: "01-31 08:08:20 F-04-50-04 SUPPLY FAILURE: T1 TEST, PUMP P1 DEFECTIVE." A BURNING SMELL WAS NOTED UPON OPENING THE PANEL HOWEVER THERE WAS NO OBSERVED SMOKE, SPARK, FLAME, OR ARCING. THE MOTOR PROTECTION SWITCH CABLE (M11008073ET), MOTOR PROTECTION SWITCH CABLE SET (F50005347), MOTOR PROTECTION SWITCH (F50005352), AND POWER CONTACTOR (F50005252) WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS RETURNED TO SERVICE FOLLOWING REPAIR. NO PARTS WERE CONFIRMED TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO REPORTED HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THIS ISSUE.

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

THE BIOMEDICAL TECHNICIAN (BIOMED) FOR A USER FACILITY REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE REPORTED ISSUE WAS DISCOVERED DURING TROUBLESHOOTING AFTER THE RO SYSTEM ALARMED DURING THE T1 TEST WITH ERROR "F-04-50-04 T1 TEST. PUMP P1 DEFECTIVE." THE BIOMED WAS ADVISED TO PLACE THE RO SYSTEM IN EMERGENCY MODE. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THE MOTOR PROTECTION SWITCH (MPS) AND CONNECTED WIRING SUSTAINED THERMAL DAMAGE. THE PARTS APPEARED BLACKENED AND CHARRED. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. THE ERROR LOG INCLUDED THE FOLLOWING ENTRY: "01-31 08:08:20 F-04-50-04 SUPPLY FAILURE:T1 TEST, PUMP P1 DEFECTIVE." A BURNING SMELL WAS NOTED UPON OPENING THE PANEL HOWEVER THERE WAS NO OBSERVED SMOKE, SPARK, FLAME, OR ARCING. THE MOTOR PROTECTION SWITCH CABLE (M11008073ET), MOTOR PROTECTION SWITCH CABLE SET (F50005347), MOTOR PROTECTION SWITCH (F50005352), AND POWER CONTACTOR (F50005252) WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS RETURNED TO SERVICE FOLLOWING REPAIR. NO PARTS WERE CONFIRMED TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO REPORTED HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THIS ISSUE.