AQUABPLUS, B2, HF 1500 KIT

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO SAMPLES WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. PHOTOGRAPHS OF THE REPORTED ISSUE WERE PROVIDED WHICH THE MANUFACTURER USED TO CONFIRM THE REPORTED ISSUE. THE THERMAL DAMAGE SUSTAINED BY THE WIRES RESULTED IN ERROR CODES W-04-52-01 AND W-02-52-03 AS HEATER H1 CAN NO LONGER WORK PROPERLY. THE BROKEN CONTACT AT THE HEATER AND THE BROKEN CONTACT OF THE INNER BIMETAL SWITCH OF THE HEATER LIKELY CAUSED BY THE HEAT EMISSION OF THE ELECTRICAL CONTACTS. IN THE CASE OF HIGH CURRENTS, WHICH IS NORMAL FOR HEATER OPERATION, COMBINED WITH A BAD ELECTRICAL CONTACT, HIGH THERMAL ENERGY (HEAT EMISSION) WILL RESULT IN OVERHEATING OF THE CABLE LUGS. IT WAS LIKELY THE CABLE LUG WAS NOT PROPERLY SEATED DURING THE MANUFACTURING PROCESS AND CAUSED THE REPORTED FAILURE PATTERN WITH INCREASED OPERATING HOURS. THE LIKELY CAUSE OF THE LOOSE CONNECTION BETWEEN CONTACTOR Q2 AND CIRCUIT BREAKER F3 IS THE SCREW CONNECTION BECOMING LOOSE DURING SHIPMENT AND NOT BEING TIGHTENED DURING THE OPERATIONAL QUALIFICATION. THIS WAS LIKELY MISSED DURING SERVICING WHICH RESULTED IN INCREASED THERMAL ENERGY AND HEAT EMISSION WHICH DAMAGED THE HOUSING PARTS OF CONTACTOR Q2 AND CIRCUIT BREAKER F3. THE TIGHTENING OF THE SCREWS AFTER SHIPMENT IS REFERENCED IN THE SERVICE MANUAL.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT MELTED WIRING WAS DISCOVERED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) HF UNIT. THE BIOMED REQUESTED ASSISTANCE WITH A REPAIR PLAN. THE POWER TO THE HF WAS SWITCHED OFF AND THE HEAT DISINFECTION TIMER WAS DEACTIVATED. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. MULTIPLE PARTS IN THE HF UNIT SUSTAINED THERMAL DAMAGE (PARTS NOT SPECIFIED). THE BIOMED COULD NOT DETERMINE THE CAUSE OF THE DAMAGE. THE BIOMED INDICATED THAT ERRORS W-04-52-01 AND W-02-52-03 WERE INITIALLY RECEIVED DURING HEAT DISINFECTION. THE BIOMED CONFIRMED THE PARTS APPEARED BURNED, CHARRED, FRIED, MELTED AND BLACKENED. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME OR ARCING REPORTED. IT WAS CONFIRMED THE SYSTEM IS PLUGGED INTO ITS OWN BREAKER. NO BLOWN FUSES WERE IDENTIFIED WITHIN THE LOCAL POWER SUPPLY. NO LOCAL POWER GRID ISSUES NOR ELECTRICAL STORMS OCCURRED ON OR AROUND THE REPORTED EVENT DATE. THE BIOMED COULD NOT CONFIRM WHETHER THE THERMAL OVERLOAD RELAY TRIPPED. AT THE TIME OF FOLLOW-UP THE RO SYSTEM REMAINED OUT OF SERVICE. IT WAS DETERMINED THAT THE HF UNIT WOULD BE REPLACED RATHER THAN REPAIRED. THE BIOMED STATED THAT PARTS WOULD BE AVAILABLE TO BE RETURNED FOR EVALUATION UPON RESOLVING THE MACHINE ISSUE.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT MELTED WIRING WAS DISCOVERED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) HF UNIT. THE BIOMED REQUESTED ASSISTANCE WITH A REPAIR PLAN. THE POWER TO THE HF WAS SWITCHED OFF AND THE HEAT DISINFECTION TIMER WAS DEACTIVATED. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. MULTIPLE PARTS IN THE HF UNIT SUSTAINED THERMAL DAMAGE (PARTS NOT SPECIFIED). THE BIOMED COULD NOT DETERMINE THE CAUSE OF THE DAMAGE. THE BIOMED INDICATED THAT ERRORS W-04-52-01 AND W-02-52-03 WERE INITIALLY RECEIVED DURING HEAT DISINFECTION. THE BIOMED CONFIRMED THE PARTS APPEARED BURNED, CHARRED, FRIED, MELTED AND BLACKENED. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME OR ARCING REPORTED. IT WAS CONFIRMED THE SYSTEM IS PLUGGED INTO ITS OWN BREAKER. NO BLOWN FUSES WERE IDENTIFIED WITHIN THE LOCAL POWER SUPPLY. NO LOCAL POWER GRID ISSUES NOR ELECTRICAL STORMS OCCURRED ON OR AROUND THE REPORTED EVENT DATE. THE BIOMED COULD NOT CONFIRM WHETHER THE THERMAL OVERLOAD RELAY TRIPPED. AT THE TIME OF FOLLOW-UP THE RO SYSTEM REMAINED OUT OF SERVICE. IT WAS DETERMINED THAT THE HF UNIT WOULD BE REPLACED RATHER THAN REPAIRED. THE BIOMED STATED THAT PARTS WOULD BE AVAILABLE TO BE RETURNED FOR EVALUATION UPON RESOLVING THE MACHINE ISSUE.

Additional Manufacturer Narrative

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