AQUABPLUS, B2, HF 2000 KIT

Description of Event or Problem

THE BIOMEDICAL TECHNICIAN (BIOMED) FOR A USER FACILITY REPORTED TO FRESENIUS TECHNICAL SERVICES THAT ERROR ¿F¿04¿51¿04 FAILURE: T1 TEST, PUMP P1S DEFECTIVE¿ WAS RECEIVED ON THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM DURING THE T1 TEST. THE BIOMED WAS ADVISED TO RUN THE RO SYSTEM IN EMERGENCY MODE IN ORDER TO BEGIN PATIENT TREATMENTS. THE BIOMED STATED UPON FOLLOW-UP THAT THE AREA TECHNICAL OPERATIONS MANAGER (ATOM) EVALUATED THE RO SYSTEM AND THERMAL DECOMPOSITION WAS DISCOVERED WITHIN STAGE 2. THE POWER SWITCH APPEARED TO BE ¿BURNT UP.¿ THERE WAS NO OBSERVED SMOKE, SPARK, FLAME, OR ARCING. THE POWER SWITCH WAS REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM WAS RETURNED TO SERVICE FOLLOWING REPAIR. NO SAMPLES ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. NO PHOTOGRAPHS ARE AVAILABLE TO BE OBTAINED FOR REVIEW. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION.

Additional Manufacturer Narrative

PLANT INVESTIGATION: THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE CAUSE OF THE REPORTED ERROR AND THERMAL DECOMPOSITION IS DETERMINED TO BE A BAD ELECTRICAL CONTACT AT THE STAGE 2 MOTOR PROTECTION SWITCH. THE CONTACT RESISTANCE AND THE PUMP CURRENT INCREASED AND LED TO INCREASED THERMAL ENERGY AT THE CONTACTS POINTS. THE CABLE LUGS CONNECTIONS/WIRING AT THE MOTOR PROTECTION SWITCH OVERHEATED AND BECAME DAMAGED/DISCOLORED FROM THE RELEASED THERMAL ENERGY AT THE BAD ELECTRICAL CONTACT AND DEVICE OPERATION WAS INTERRUPTED. THIS FAILURE IS A KNOWN ISSUE. CORRECTIVE ACTIONS HAVE BEEN DEFINED AND ARE UNDER IMPLEMENTATION. A NEW DESIGN OF THE MOTOR PROTECTION SWITCH AND ITS WIRING IS DEVELOPED BUT IS CURRENTLY NOT RELEASED FOR THE US MARKET. ACCORDING TO THE PROVIDED INFORMATION, THE STAGE 2 MOTOR PROTECTION SWITCH WAS REPLACED TO RESOLVE THE ISSUE. IT IS RECOMMENDED TO REPLACE THE WIRING AND THE MOTOR PROTECTION SWITCH IN STAGE 1 AND STAGE 2 TO AVOID ADDITIONAL FAILURES.