AQUABPLUS, B2, HF 2500 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

THE BIOMEDICAL TECHNICIAN (BIOMED) FOR A USER FACILITY REPORTED TO FRESENIUS TECHNICAL SERVICES THAT A VOLTAGE ISSUE OCCURRED WITH THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM AND A BLOWN FUSE WAS IDENTIFIED IN THE PRE-TREATMENT POWER PANEL. FRESENIUS ADVISED THE CUSTOMER ABOUT REMOVING WIRING FROM THE PANEL BOX AS REQUESTED. IN A SUBSEQUENT CALL TO FRESENIUS ABOUT THE ISSUE, THE BIOMED REPORTED THAT THERMAL DECOMPOSITION WAS IDENTIFIED AT THE WIRING OF THE STAGE 2 MOTOR PROTECTION SWITCH (MPS). THE CUSTOMER WAS ADVISED TO ORDER A REPLACEMENT WIRE SET AND OPERATE THE RO SYSTEM FROM STAGE 1 EMERGENCY MODE UNTIL THE REPAIR CAN BE MADE. THERE WAS NO REPORTED HARM TO ANY INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THE BIOMED CONFIRMED THAT THERMAL DAMAGE WAS IDENTIFIED ON THE STAGE 2 POWER CORD AT THE MOTOR PROTECTION SWITCH (MPS). THE BIOMED STATED THAT THE WIRES AND CONNECTORS WERE MELTED. THE BIOMED DID NOT KNOW THE CAUSE FOR THE REPORTED ISSUE. IT WAS NOTED THAT A PUMP FAILURE ALARM WAS RECEIVED IN SUPPLY MODE (ERROR CODE NOT PROVIDED). NO SPARKS OR FLAMES WERE OBSERVED. THE THERMAL OVERLOAD RELAY DID NOT TRIP. THE BIOMED STATED THAT THE POWER CORD WAS REPLACED TO RESOLVE THE REPORTED ISSUE. NO SAMPLES WERE REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Description of Event or Problem

THE BIOMEDICAL TECHNICIAN (BIOMED) FOR A USER FACILITY REPORTED TO FRESENIUS TECHNICAL SERVICES THAT A VOLTAGE ISSUE OCCURRED WITH THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM AND A BLOWN FUSE WAS IDENTIFIED IN THE PRE-TREATMENT POWER PANEL. FRESENIUS ADVISED THE CUSTOMER ABOUT REMOVING WIRING FROM THE PANEL BOX AS REQUESTED. IN A SUBSEQUENT CALL TO FRESENIUS ABOUT THE ISSUE, THE BIOMED REPORTED THAT THERMAL DECOMPOSITION WAS IDENTIFIED AT THE WIRING OF THE STAGE 2 MOTOR PROTECTION SWITCH (MPS). THE CUSTOMER WAS ADVISED TO ORDER A REPLACEMENT WIRE SET AND OPERATE THE RO SYSTEM FROM STAGE 1 EMERGENCY MODE UNTIL THE REPAIR CAN BE MADE. THERE WAS NO REPORTED HARM TO ANY INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THE BIOMED CONFIRMED THAT THERMAL DAMAGE WAS IDENTIFIED ON THE STAGE 2 POWER CORD AT THE MOTOR PROTECTION SWITCH (MPS). THE BIOMED STATED THAT THE WIRES AND CONNECTORS WERE MELTED. THE BIOMED DID NOT KNOW THE CAUSE FOR THE REPORTED ISSUE. IT WAS NOTED THAT A PUMP FAILURE ALARM WAS RECEIVED IN SUPPLY MODE (ERROR CODE F¿04¿50¿04 FAILURE: T1 TEST, PUMP P1 DEFECTIVE). NO SPARKS OR FLAMES WERE OBSERVED. THE THERMAL OVERLOAD RELAY DID NOT TRIP. THE BIOMED STATED THAT THE POWER CORD WAS REPLACED TO RESOLVE THE REPORTED ISSUE. NO SAMPLES WERE REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO SAMPLE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER A PHOTOGRAPH WAS PROVIDED BY THE CUSTOMER AND USED BY THE MANUFACTURER TO CONFIRM THE REPORTED EVENT. THIS FAILURE CAN BE ATTRIBUTED TO BAD ELECTRICAL CONTACTING BETWEEN THE CABLE LUGS AND THEIR CONTACT PINS AT THE MOTOR PROTECTION SWITCH. THE CONTACT RESISTANCE INCREASED AND THE PUMP CURRENT LED TO INCREASED THERMAL ENERGY AT THE CONTACTS POINTS. THE CABLE LUGS AT THE MOTOR PROTECTION SWITCH OVERHEATED AND DISCOLORED FROM THE RELEASED THERMAL ENERGY AT THE BAD ELECTRICAL CONTACT. DUE TO THE BAD ELECTRICAL CONTACT, THE THERMAL OVERLOAD SWITCH BECAME UNBALANCED AND TRIPPED AS INTENDED. THIS FAILURE IS A KNOWN ISSUE. THE DESIGN OF THE ELECTRICAL CONTACT OF THIS APPLICATION WAS DETERMINED TO BE INADEQUATE. CORRECTIVE ACTIONS HAVE BEEN DEFINED AND ARE UNDER IMPLEMENTATION. A NEW DESIGN OF THE MOTOR PROTECTION SWITCH AND ITS WIRING HAS BEEN DEVELOPED BUT IS CURRENTLY NOT RELEASED FOR THE US MARKET. ACCORDING TO THE INTAKE INFORMATION REPLACEMENT PARTS WERE ORDERED. IT IS RECOMMENDED TO REPLACE THE WIRING AND THE MOTOR PROTECTION SWITCH IN STAGE 1 AND STAGE 2 TO PREVENT ADDITIONAL FAILURES.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B3 (DATE OF EVENT), B5 (EVENT DESCRIPTION) 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 A VOLTAGE ISSUE OCCURRED WITH THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM AND A BLOWN FUSE WAS IDENTIFIED IN THE PRE-TREATMENT POWER PANEL. FRESENIUS ADVISED THE CUSTOMER ABOUT REMOVING WIRING FROM THE PANEL BOX AS REQUESTED. IN A SUBSEQUENT CALL TO FRESENIUS ABOUT THE ISSUE, THE BIOMED REPORTED THAT THERMAL DECOMPOSITION WAS IDENTIFIED AT THE WIRING OF THE STAGE 2 MOTOR PROTECTION SWITCH (MPS). THE CUSTOMER WAS ADVISED TO ORDER A REPLACEMENT WIRE SET AND OPERATE THE RO SYSTEM FROM STAGE 1 EMERGENCY MODE UNTIL THE REPAIR CAN BE MADE. THERE WAS NO REPORTED HARM TO ANY INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THE BIOMED CONFIRMED THAT THERMAL DAMAGE WAS IDENTIFIED ON THE STAGE 2 POWER CORD AT THE MOTOR PROTECTION SWITCH (MPS). THE BIOMED STATED THAT THE WIRES AND CONNECTORS WERE MELTED. THE BIOMED DID NOT KNOW THE CAUSE FOR THE REPORTED ISSUE. IT WAS NOTED THAT A PUMP FAILURE ALARM WAS RECEIVED IN SUPPLY MODE (ERROR CODE F¿04¿50¿04 FAILURE: T1 TEST, PUMP P1 DEFECTIVE). NO SPARKS OR FLAMES WERE OBSERVED. THE THERMAL OVERLOAD RELAY DID NOT TRIP. THE BIOMED STATED THAT THE POWER CORD WAS REPLACED TO RESOLVE THE REPORTED ISSUE. NO SAMPLES WERE REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.