AQUABPLUS, HF 1000

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5 THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

Description of Event or Problem

IT WAS REPORTED TO FRESENIUS THAT THERMAL DAMAGE WAS DISCOVERED IN THE PRINCIPAL SWITCH OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THIS INDICATION OF THERMAL DAMAGE REPRESENTS A FAILURE IN THE ELECTRICAL SYSTEM. THE PRINCIPAL SWITCH WAS REPLACED TO RESOLVE THE REPORTED ISSUE. THERE WAS NO REPORTED PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANYONE AS A RESULT OF THE IDENTIFIED THERMAL DAMAGE. IT HAS NOT BEEN INDICATED THAT A SAMPLE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THE CUSTOMER REPORTED THAT THE MAIN SWITCH OVERLOADED IN STANDBY MODE AND THE REVERSE OSMOSIS (RO) SYSTEM COULD NOT POWER ON. WIRE CABLES FROM THE MAIN SWITCH TO THE ELECTRIC CONTACTOR MELTED AND TERMINALS ON THE SWITCH APPEARED BURNED. THE SUSPECTED CAUSE OF THE FAILURE IS THE GENERATED ELECTRICAL LOAD EXCEEDING THE CAPACITY OF THE WIRING. THE MAIN SWITCH DOES NOT SUPPORT THE CURRENT LOAD. THERE WAS NO ALARMS RECEIVED. THERE WAS NO OBSERVED SMELL, SMOKE, SPARK FLAME OR ARCING THE ONLY INDICATION OF AN ISSUE WAS THE MAIN SWITCH TRIPPING AND THE MELTED WIRE CABLES IDENTIFIED DURING INSPECTION. NO BLOWN FUSES WERE IDENTIFIED. NO POWER FAILURE WAS REPORTED. THE EQUIPMENT IS CONNECTED TO THE CEE PLUG 16A. IT IS ALSO CONNECTED TO THE CLINIC GROUND CIRCUIT. THE MAIN SWITCH (F40006253) WAS REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM HAS BEEN RETURNED TO SERVICE. NO SAMPLE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER. THERE WAS NO PATIENT INVOLVEMENT REGARDING THE REPORTED ISSUE.

Additional Manufacturer Narrative

PLANT INVESTIGATION: PHYSICAL EVALUATION OF A SAMPLE WAS NOT REQUIRED FOR THIS CASE. THE REPORTED ISSUE WAS CONFIRMED USING THE PROVIDED INFORMATION. THE CAUSE OF THE REPORTED FAILURE WAS DETERMINED TO BE A BAD ELECTRICAL CONTACT OF THE WIRING AT THE MOTOR PROTECTION SWITCH. THE DAMAGE RESULTED FROM EITHER (1) THE ELECTRICAL CONTACT AT THE MOTOR PROTECTION SWITCH PUMP P1(S) RUNNING WITH ONLY TWO LINE CONDUCTORS OR (2) THE INNER BIMETAL CONTACT OF THE MOTOR PROTECTION TRIPPING FROM INCREASED TEMPERATURE CAUSED BY THE TRANSITION RESISTANCE OF THE ELECTRICAL CONTACT. BOTH ISSUES RESULT IN HIGHER CURRENTS AND HIGHER THERMAL ENERGY, AND ULTIMATELY THERMAL DECOMPOSITION. THIS FAILURE IS A KNOWN ISSUE. A ROOT CAUSE ANALYSIS IS IN PROGRESS AND CORRECTIVE/PREVENTIVE ACTIONS WILL BECOME AVAILABLE WITH AN IMPROVED DESIGN FOR THE ELECTRICAL MONITOR, WHICH INCLUDES THE WIRING AT THE MAIN SWITCH (THE MOTOR PROTECTION SWITCH IN THE CURRENT DESIGN). THE IMPROVED DESIGN IS CURRENTLY NOT AVAILABLE FOR THE AFFECTED MARKET SEGMENT, BUT THE RELEASE IS PLANNED BY COMPLETION OF THE DESIGN CHANGE. ACCORDING TO THE PROVIDED INFORMATION, THE MOTOR PROTECTION SWITCH, CONTACTOR AND THE WIRING WERE REPLACED TO SOLVE THE ISSUE. THE CURRENT STATUS OF THE MACHINE IS UNKNOWN. IT IS RECOMMENDED, IF NOT ALREADY DONE, TO REPLACE THE WIRING AND THE MOTOR PROTECTION SWITCH IN STAGE 1 AND STAGE 2 WITH THE AVAILABLE DESIGN. ONLY INSTALLATION OF MANUFACTURER SPARE PARTS IS ADVISED.

Description of Event or Problem

IT WAS REPORTED TO FRESENIUS THAT THERMAL DAMAGE WAS DISCOVERED IN THE PRINCIPAL SWITCH OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THIS INDICATION OF THERMAL DAMAGE REPRESENTS A FAILURE IN THE ELECTRICAL SYSTEM. THE PRINCIPAL SWITCH WAS REPLACED TO RESOLVE THE REPORTED ISSUE. THERE WAS NO REPORTED PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANYONE AS A RESULT OF THE IDENTIFIED THERMAL DAMAGE. IT HAS NOT BEEN INDICATED THAT A SAMPLE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THE CUSTOMER REPORTED THAT THE MAIN SWITCH OVERLOADED IN STANDBY MODE AND THE REVERSE OSMOSIS (RO) SYSTEM COULD NOT POWER ON. WIRE CABLES FROM THE MAIN SWITCH TO THE ELECTRIC CONTACTOR MELTED AND TERMINALS ON THE SWITCH APPEARED BURNED. THE SUSPECTED CAUSE OF THE FAILURE IS THE GENERATED ELECTRICAL LOAD EXCEEDING THE CAPACITY OF THE WIRING. THE MAIN SWITCH DOES NOT SUPPORT THE CURRENT LOAD. THERE WAS NO ALARMS RECEIVED. THERE WAS NO OBSERVED SMELL, SMOKE, SPARK FLAME OR ARCING THE ONLY INDICATION OF AN ISSUE WAS THE MAIN SWITCH TRIPPING AND THE MELTED WIRE CABLES IDENTIFIED DURING INSPECTION. NO BLOWN FUSES WERE IDENTIFIED. NO POWER FAILURE WAS REPORTED. THE EQUIPMENT IS CONNECTED TO THE CEE PLUG 16A. IT IS ALSO CONNECTED TO THE CLINIC GROUND CIRCUIT. THE MAIN SWITCH (F40006253) WAS REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM HAS BEEN RETURNED TO SERVICE. NO SAMPLE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER. THERE WAS NO PATIENT INVOLVEMENT REGARDING THE REPORTED 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

IT WAS REPORTED TO FRESENIUS THAT THERMAL DAMAGE WAS DISCOVERED IN THE PRINCIPAL SWITCH OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THIS INDICATION OF THERMAL DAMAGE REPRESENTS A FAILURE IN THE ELECTRICAL SYSTEM. THE PRINCIPAL SWITCH WAS REPLACED TO RESOLVE THE REPORTED ISSUE. THERE WAS NO REPORTED PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANYONE AS A RESULT OF THE IDENTIFIED THERMAL DAMAGE. IT HAS NOT BEEN INDICATED THAT A SAMPLE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.