AQUABPLUS, B2, HF 1500 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

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS THAT THERMAL DAMAGE WAS IDENTIFIED ON THE STAGE 2 MOTOR PROTECTION SWITCH OF THE AQUAB PLUS REVERSE OSMOSIS (RO) SYSTEM. THE THERMAL DAMAGE WAS LOCATED AT THE CONNECTION BETWEEN THE SWITCH AND THE SHORT CABLE. THE REPORTED ISSUE WAS DISCOVERED UPON MACHINE REPAIR. THE BIOMED INITIALLY CONTACTED FRESENIUS WHEN THE RO SYSTEM FAILED THE T1 TEST. THE ERROR F¿04¿51¿04 WAS DISPLAYED WITH THE MESSAGE "FAILURE: T1 TEST, PUMP P1S DEFECTIVE." THE BIOMED STATED THAT THE MOTOR PROTECTION SWITCH OF THE SECOND STAGE OF THE RO HAD SHORTED AND TRIPPED. THERE WAS NO OBSERVED SMOKE, SPARK, FLAME, OR ARCING. A BURNING SMELL WAS NOTED. NO BLOWN FUSES WERE IDENTIFIED. THE THERMAL OVERLOAD RELAY DID NOT TRIP. THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. THE BIOMED SUSPECTS THAT A POWER ISSUE OCCURRED AROUND THE EVENT DATE. IT WAS NOTED THAT POWER ISSUES ARE COMMON AT THE FACILITY ON WINDY DAYS. THE POWER FLICKERS MOMENTARILY THEN RETURNS. THE BIOMED STATED THAT THE SWITCH AND CABLE WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM WAS RETURNED TO SERVICE. NO PARTS ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANYONE AS A RESULT OF THE REPORTED ISSUE.

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO SAMPLES WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER THE MANUFACTURER CONFIRMED THE REPORTED EVENT BASED ON THE PROVIDED INFORMATION. THE COMPLAINT INVESTIGATION DETERMINED THAT THE LIKELY CAUSE OF THE THERMAL DAMAGE WAS A LOOSE ELECTRICAL CONTACT AT THE MOTOR PROTECTION SWITCH. IN SUCH AN INSTANCE THE PUMP WILL RUN ONLY WITH TWO LINE CONDUCTORS, RESULTING IN HIGHER CURRENT AND HIGHER THERMAL ENERGY. THE CABLE LUGS AT THE MOTOR PROTECTION SWITCH CAN GET OVERHEATED AND DISCOLORED BY THE RELEASED THERMAL ENERGY AT THE BAD ELECTRICAL CONTACT. THIS IS A KNOWN FAILURE. A DESIGN CHANGE FOR A DIFFERENT MOTOR PROTECTION SWITCH TYPE AND ELECTRICAL CONNECTION IS GOING TO BE IMPLEMENTED. THE DESIGN CHANGE PROCESS IS ONGOING. THE NEW DESIGN IS CURRENTLY NOT AVAILABLE FOR THE US MARKET. IN THIS INSTANCE THE SWITCH AND CONNECTED WIRING WERE REPLACED TO RESOLVE THE REPORTED ISSUE. IT IS RECOMMENDED, IF NOT ALREADY DONE, TO REPLACE THE MOTOR PROTECTION SWITCH AND BLACK CONNECTION WIRES AGAINST THE IMPROVED DESIGN IN STAGE 1 AND STAGE 2.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS THAT THERMAL DAMAGE WAS IDENTIFIED ON THE STAGE 2 MOTOR PROTECTION SWITCH OF THE AQUAB PLUS REVERSE OSMOSIS (RO) SYSTEM. THE THERMAL DAMAGE WAS LOCATED AT THE CONNECTION BETWEEN THE SWITCH AND THE SHORT CABLE. THE REPORTED ISSUE WAS DISCOVERED UPON MACHINE REPAIR. THE BIOMED INITIALLY CONTACTED FRESENIUS WHEN THE RO SYSTEM FAILED THE T1 TEST. THE ERROR F¿04¿51¿04 WAS DISPLAYED WITH THE MESSAGE "FAILURE: T1 TEST, PUMP P1S DEFECTIVE." THE BIOMED STATED THAT THE MOTOR PROTECTION SWITCH OF THE SECOND STAGE OF THE RO HAD SHORTED AND TRIPPED. THERE WAS NO OBSERVED SMOKE, SPARK, FLAME, OR ARCING. A BURNING SMELL WAS NOTED. NO BLOWN FUSES WERE IDENTIFIED. THE THERMAL OVERLOAD RELAY DID NOT TRIP. THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. THE BIOMED SUSPECTS THAT A POWER ISSUE OCCURRED AROUND THE EVENT DATE. IT WAS NOTED THAT POWER ISSUES ARE COMMON AT THE FACILITY ON WINDY DAYS. THE POWER FLICKERS MOMENTARILY THEN RETURNS. THE BIOMED STATED THAT THE SWITCH AND CABLE WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM WAS RETURNED TO SERVICE. NO PARTS ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANYONE AS A RESULT OF THE REPORTED ISSUE.