AQUABPLUS, B2, HF 2500 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 THAT THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE THERMAL DECOMPOSITION WAS NOTED IN STAGE 1. THE L2 WIRE CONNECTOR LEADING TO THE ON/OFF PUSH BUTTON WAS CHARRED. THE REPORTED ISSUE WAS NOTED DURING MACHINE REPAIR. THE SYSTEM WAS INITIALLY EVALUATED WHEN THE RO SYSTEM WAS NOT COMPLETING HEAT DISINFECTION. THERE WERE NO DIAGNOSTIC MESSAGES OR AUDIBLE ALARMS RECEIVED. NO RELEVANT ALARMS WERE NOTED IN THE MACHINE HISTORY. THE HEAT DISINFECTION IS PROGRAMMED TO RUN ON SUNDAYS AT 10:30 AM AND THE TIMER WAS ACTIVATED. THE ON/OFF PUSH BUTTON WAS REPLACED TO RESOLVE THE INITIAL ISSUE. THE BIOMED STATED THAT THE ELECTRICAL WIRING WILL REQUIRE REPLACEMENT IN ORDER TO RESOLVE THE IDENTIFIED THERMAL DECOMPOSITION. NO SAMPLES ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. NO PHOTOGRAPHS WERE AVAILABLE FOR ANALYSIS. THE MACHINE FILES WERE OBTAINED FOR REVIEW BY THE MANUFACTURER. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE.

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 DECOMPOSITION WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE THERMAL DECOMPOSITION WAS NOTED IN STAGE 1. THE L2 WIRE CONNECTOR LEADING TO THE ON/OFF PUSH BUTTON WAS CHARRED. THE REPORTED ISSUE WAS NOTED DURING MACHINE REPAIR. THE SYSTEM WAS INITIALLY EVALUATED WHEN THE RO SYSTEM WAS NOT COMPLETING HEAT DISINFECTION. THERE WERE NO DIAGNOSTIC MESSAGES OR AUDIBLE ALARMS RECEIVED. NO RELEVANT ALARMS WERE NOTED IN THE MACHINE HISTORY. THE HEAT DISINFECTION IS PROGRAMMED TO RUN ON SUNDAYS AT 10:30 AM AND THE TIMER WAS ACTIVATED. THE ON/OFF PUSH BUTTON WAS REPLACED TO RESOLVE THE INITIAL ISSUE. THE BIOMED STATED THAT THE ELECTRICAL WIRING WILL REQUIRE REPLACEMENT IN ORDER TO RESOLVE THE IDENTIFIED THERMAL DECOMPOSITION. NO SAMPLES ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. NO PHOTOGRAPHS WERE AVAILABLE FOR ANALYSIS. THE MACHINE FILES WERE OBTAINED FOR REVIEW BY THE MANUFACTURER. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE.