AQUABPLUS, B2, HF 2000 KIT

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H3 PLANT INVESTIGATION: PHOTOGRAPHS WERE PROVIDED BY THE CUSTOMER WHICH WERE USED BY THE MANUFACTURER TO CONFIRM THE REPORTED ISSUE. THE MANUFACTURER DETERMINED THE IDENTIFIED THERMAL DAMAGE IS MOST LIKELY THE RESULT OF A BAD ELECTRICAL CONTACT AT THE PINS OF THE MOTOR PROTECTION SWITCH, WHICH CAN CAUSE TRANSITION RESISTANCE AND INCREASED TEMPERATURE/THERMAL ENERGY AT THE CONTACT PINS. THIS FAILURE REPRESENTS A KNOWN ISSUE. A NEW DESIGN OF THE MOTOR PROTECTION SWITCH AND ITS WIRING HAVE BEEN DEVELOPED BUT HAS NOT BEEN RELEASED TO THE US MARKET. IT IS RECOMMENDED TO REPLACE THE WIRING WITH INCLUDED BLADE RECEPTACLES IN BOTH STAGES UNTIL THE PART BECOMES AVAILABLE TO THE US MARKET. IN THIS CASE, THE MOTOR PROTECTION SWITCH AND THE OVERHEATED WIRING IN STAGE 1 WAS PLANNED TO BE REPLACED AND SPARE PARTS WERE ORDERED. AS A TEMPORARY FIX THE WIRES WITH BLADE RECEPTACLES WERE RECONNECTED TO THE MOTOR PROTECTION SWITCH.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DAMAGE WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE STAGE 1 MOTOR PROTECTION SWITCH AND WIRING HARNESS APPEARED CHARRED AND SLIGHTLY MELTED. THE REPORTED ISSUE WAS DISCOVERED DURING MACHINE REPAIR WHEN THE MACHINE WAS EVALUATED FOR FAILING TO POWER ON. THE BIOMED WAS ABLE TO TIGHTEN THE CONNECTIONS TO POWER ON THE RO SYSTEM. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. THE SUSPECTED CAUSE OF THE REPORTED FAILURE WAS A LOOSE CONNECTION. THERE WERE NO ALARM CODES DISPLAYED. NO ONE WAS AT THE CLINIC AT THE TIME OF THE FAILURE. THE OPERATING MODE AT THE INITIAL TIME OF FAILURE WAS UNKNOWN. THERE WAS NO REPORTED SMOKE, SPARK, FLAME, OR ARCING. THE THERMAL OVERLOAD RELAY DID NOT TRIP. NO BLOWN FUSES WERE IDENTIFIED IN THE LOCAL POWER SUPPLY. THE MACHINE IS PLUGGED INTO ITS OWN BREAKER. THERE WERE NO LOCAL POWER GRID ISSUES ON OR AROUND THE REPORTED EVENT DATE. REPLACEMENTS FOR THE MOTOR PROTECTION SWITCH AND HARNESS WERE ORDERED. THE COMPLAINT SAMPLES WILL BE RETURNED TO THE MANUFACTURER UPON INSTALLATION OF THE REPLACEMENT PARTS.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DAMAGE WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE STAGE 1 MOTOR PROTECTION SWITCH AND WIRING HARNESS APPEARED CHARRED AND SLIGHTLY MELTED. THE REPORTED ISSUE WAS DISCOVERED DURING MACHINE REPAIR WHEN THE MACHINE WAS EVALUATED FOR FAILING TO POWER ON. THE BIOMED WAS ABLE TO TIGHTEN THE CONNECTIONS TO POWER ON THE RO SYSTEM. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. THE SUSPECTED CAUSE OF THE REPORTED FAILURE WAS A LOOSE CONNECTION. THERE WERE NO ALARM CODES DISPLAYED. NO ONE WAS AT THE CLINIC AT THE TIME OF THE FAILURE. THE OPERATING MODE AT THE INITIAL TIME OF FAILURE WAS UNKNOWN. THERE WAS NO REPORTED SMOKE, SPARK, FLAME, OR ARCING. THE THERMAL OVERLOAD RELAY DID NOT TRIP. NO BLOWN FUSES WERE IDENTIFIED IN THE LOCAL POWER SUPPLY. THE MACHINE IS PLUGGED INTO ITS OWN BREAKER. THERE WERE NO LOCAL POWER GRID ISSUES ON OR AROUND THE REPORTED EVENT DATE. REPLACEMENTS FOR THE MOTOR PROTECTION SWITCH AND HARNESS WERE ORDERED. THE COMPLAINT SAMPLES WILL BE RETURNED TO THE MANUFACTURER UPON INSTALLATION OF THE REPLACEMENT PARTS.

Additional Manufacturer Narrative

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