AQUABPLUS, B2, HF 2000 KIT

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER THE CASE DETAILS WERE USED TO CONFIRM THE REPORTED ISSUE. THE MOST LIKELY FAILURE CAUSE FOR THE THERMAL DAMAGE CAN BE ATTRIBUTED TO POOR ELECTRICAL CONTACTING BETWEEN AT THE MOTOR PROTECTION SWITCH. THE THERMAL DAMAGE OCCURRED DUE TO HIGH CONTACT RESISTANCE AND THERMAL POWER LOSS AT THE BAD CONTACTING CONNECTIONS. AS HIGHER CURRENTS OCCUR, THE WIRES AND CABLE LUGS ARE EXPOSED TO HIGHER TEMPERATURES RESPECTIVELY, RESULTING IN THE IDENTIFIED THERMAL DAMAGE. THIS ISSUE IS A KNOWN FAILURE. CORRECTIVE ACTIONS HAVE BEEN DEFINED AND IMPLEMENTED. THE WIRING HAS BEEN REDESIGNED. THIS DESIGN CHANGE WAS RELEASED. ACCORDING THE AVAILABLE INFORMATION, THE PROBLEM WAS SOLVED BY REPLACING THE MOTOR PROTECTION SWITCH STAGE 1 AND ITS CONNECTED WIRING. A DEVICE HISTORY RECORD REVIEW IS NOT REQUIRED AS THE PRODUCT WAS MANUFACTURED PRIOR TO THE REDESIGN OF THE WIRING.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE BIOMED EVALUATED THE MACHINE FOR A T1 TEST FAILURE WHEN THE ISSUE WAS DISCOVERED. ERROR F-04-50-04 WAS RECEIVED ALONG WITH A PUMP P1 DEFECTIVE MESSAGE. THE BIOMED CONFIRMED THE REPORTED EVENT DURING FOLLOW-UP AND PROVIDED ADDITIONAL INFORMATION. THE THERMAL DECOMPOSITION WAS IDENTIFIED ON THE STAGE 1 MOTOR PROTECTION SWITCH AND WIRING. THE BIOMED DESCRIBED THE WIRE CONNECTIONS AT THE SWITCH AS BLACK AND DISCOLORED. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME OR ARCING. A BLOWN FUSE WAS ALSO IDENTIFIED WITHIN THE EXTERNAL POWER DISCONNECT. THE THERMAL OVERLOAD RELAY DID NOT TRIP. THERE WERE NO LOCAL POWER GRID ISSUES OR ELECTRICAL STORMS AT THE FACILITY ON OR AROUND THE REPORTED EVENT DATE. IT WAS CONFIRMED THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. THE MOTOR PROTECTION SWITCH AND WIRING WERE REPLACED WITH AVAILABLE SPARES TO RESOLVE THE REPORTED ISSUE. THE BLOWN FUSE WAS ALSO REPLACED. THE BIOMED STATED THAT REPLACEMENTS WERE ALSO ORDERED FOR THE STAGE 2 SWITCH AND WIRING AND HAVE BEEN INSTALLED. THE RO SYSTEM HAS BEEN RETURNED TO FULL OPERATION. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. NO PARTS WERE REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

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 DECOMPOSITION WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE BIOMED EVALUATED THE MACHINE FOR A T1 TEST FAILURE WHEN THE ISSUE WAS DISCOVERED. ERROR F-04-50-04 WAS RECEIVED ALONG WITH A PUMP P1 DEFECTIVE MESSAGE. THE BIOMED CONFIRMED THE REPORTED EVENT DURING FOLLOW-UP AND PROVIDED ADDITIONAL INFORMATION. THE THERMAL DECOMPOSITION WAS IDENTIFIED ON THE STAGE 1 MOTOR PROTECTION SWITCH AND WIRING. THE BIOMED DESCRIBED THE WIRE CONNECTIONS AT THE SWITCH AS BLACK AND DISCOLORED. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME OR ARCING. A BLOWN FUSE WAS ALSO IDENTIFIED WITHIN THE EXTERNAL POWER DISCONNECT. THE THERMAL OVERLOAD RELAY DID NOT TRIP. THERE WERE NO LOCAL POWER GRID ISSUES OR ELECTRICAL STORMS AT THE FACILITY ON OR AROUND THE REPORTED EVENT DATE. IT WAS CONFIRMED THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. THE MOTOR PROTECTION SWITCH AND WIRING WERE REPLACED WITH AVAILABLE SPARES TO RESOLVE THE REPORTED ISSUE. THE BLOWN FUSE WAS ALSO REPLACED. THE BIOMED STATED THAT REPLACEMENTS WERE ALSO ORDERED FOR THE STAGE 2 SWITCH AND WIRING AND HAVE BEEN INSTALLED. THE RO SYSTEM HAS BEEN RETURNED TO FULL OPERATION. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. NO PARTS WERE REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.