AQUABPLUS, B2, HF 2000 KIT

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DAMAGE WAS IDENTIFIED ON THE RED/GREEN MOTOR PROTECTION SWITCH (MPS) IN STAGE 1 OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THERE WAS EVIDENCE OF MELTING AT PIN #1 ON THE MPS AS WELL ON THE COVER OF THE CABLES THAT ATTACHED TO THE PIN. THE COVER PANEL HAD FELT HOT AND THE PAINT ON THE INSIDE COVER HAD BUBBLED. A HOT ELECTRICAL SMELL WAS ALSO OBSERVED. THERE WAS NO OBSERVED SMOKE, SPARK, OR FLAME. THE REPORTED ISSUE WAS DISCOVERED DURING MACHINE REPAIR. THE BIOMED STATED THAT INITIALLY POWER WAS LOST ON THE RO SYSTEM IN SUPPLY MODE. THERE WERE NO ALARM CODES RECEIVED. THE SYSTEM COULD BE REBOOTED BUT THE MPS WOULD TRIP AGAIN AND THE SYSTEM WOULD POWER OFF. THE BIOMED COULD NOT CONFIRM WHETHER THE THERMAL OVERLOAD RELAY TRIPPED. NO BLOWN FUSES WERE IDENTIFIED IN THE LOCAL POWER SUPPLY. THERE WERE NO LOCAL POWER GRID ISSUES ON OR AROUND THE REPORTED EVENT DATE. THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. THE BIOMED STATED THAT THE MPS WAS REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM HAS BEEN RETURNED TO SERVICE. THE BIOMED CONFIRMED THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANYONE AS A RESULT OF DISCOVERING THE THERMAL DAMAGE. THE BIOMED CONFIRMED THAT THE COMPLAINT SAMPLE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

PLANT INVESTIGATION: THE REPORTED ISSUE WAS CONFIRMED BY THE MANUFACTURER BASED ON THE FEEDBACK PROVIDED BY THE CUSTOMER. IT WAS DETERMINED THAT THE TRANSITION RESISTANCE AT THE PINS OF THE MOTOR PROTECTION DID CAUSE INCREASED THERMAL ENERGY AT THE BLADE RECEPTACLE, THEREFORE THE HOUSING OF THE BLADE RECEPTACLE OVERHEATED AND DEFORMED. THE MENTIONED WIRING WITH INCLUDED CRIMP CONNECTION AND BLADE RECEPTACLES ARE SUPPLIER PARTS AND A MANUFACTURING FAILURE CANNOT BE EXCLUDED OR CONFIRMED AS FAILURE CAUSE. AS NO DEFECTIVE PARTS ARE AVAILABLE, NO SUPPLIER NON CONFORMITY CAN BE SUBMITTED. THE ISSUE WAS RESOLVED WITH REPLACEMENT OF THE MOTOR PROTECTION SWITCH. A REVIEW OF SIMILAR COMPLAINTS WAS PERFORMED. THIS IS A KNOWN ISSUE WHOSE RISK WAS RATED AS BROADLY ACCEPTABLE. THE DEVICE HISTORY RECORD WAS REVIEWED, NO ISSUES WITH THE WIRING OR MOTOR PROTECTION SWITCH WAS DETERMINED DURING THE TEST PROCEDURE.

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 DAMAGE WAS IDENTIFIED ON THE RED/GREEN MOTOR PROTECTION SWITCH (MPS) IN STAGE 1 OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THERE WAS EVIDENCE OF MELTING AT PIN #1 ON THE MPS AS WELL ON THE COVER OF THE CABLES THAT ATTACHED TO THE PIN. THE COVER PANEL HAD FELT HOT AND THE PAINT ON THE INSIDE COVER HAD BUBBLED. A HOT ELECTRICAL SMELL WAS ALSO OBSERVED. THERE WAS NO OBSERVED SMOKE, SPARK, OR FLAME. THE REPORTED ISSUE WAS DISCOVERED DURING MACHINE REPAIR. THE BIOMED STATED THAT INITIALLY POWER WAS LOST ON THE RO SYSTEM IN SUPPLY MODE. THERE WERE NO ALARM CODES RECEIVED. THE SYSTEM COULD BE REBOOTED BUT THE MPS WOULD TRIP AGAIN AND THE SYSTEM WOULD POWER OFF. THE BIOMED COULD NOT CONFIRM WHETHER THE THERMAL OVERLOAD RELAY TRIPPED. NO BLOWN FUSES WERE IDENTIFIED IN THE LOCAL POWER SUPPLY. THERE WERE NO LOCAL POWER GRID ISSUES ON OR AROUND THE REPORTED EVENT DATE. THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. THE BIOMED STATED THAT THE MPS WAS REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM HAS BEEN RETURNED TO SERVICE. THE BIOMED CONFIRMED THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANYONE AS A RESULT OF DISCOVERING THE THERMAL DAMAGE. THE BIOMED CONFIRMED THAT THE COMPLAINT SAMPLE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.