AQUABPLUS, B2, HF 1500 KIT

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND PHOTOGRAPHS WERE NOT PROVIDED FOR REVIEW. HOWEVER THE MANUFACTURER CONFIRMED THE REPORTED EVENT BASED ON THE PROVIDED INFORMATION. THE CAUSE FOR THE REPORTED EVENT WAS ATTRIBUTED TO THE FAILURE TO A BAD ELECTRICAL CONTACT BETWEEN THE CABLE LUGS AND THEIR CONTACT PINS AT THE MOTOR PROTECTION SWITCH. THE CONTACT RESISTANCE INCREASED AND THE PUMP CURRENT LED TO INCREASED THERMAL ENERGY AT THE CONTACTS POINTS. THE CABLE LUGS AT THE MOTOR PROTECTION SWITCH OVERHEATED AND DISCOLORED FROM THE RELEASED THERMAL ENERGY AT THE BAD ELECTRICAL CONTACT. POWER FLUCTUATIONS ARE A CONTRIBUTING FACTOR WHICH COULD LEAD TO TRIPPED THERMAL OVERLOAD SWITCH IN ADDITION TO THE THERMAL DAMAGE AT THE BLADE RECEPTACLES. TEMPORARY MISSING LINE AND/OR LINE FLUCTUATIONS IN THE LOCAL POWER GRID (BAD ENVIRONMENTAL CONDITIONS) COULD ALSO CAUSE AN UNBALANCED LOAD AND THE MOTOR PROTECTION OR THERMAL OVERLOAD RELAY SWITCH TRIPS AS INTENDED. LINE FLUCTUATIONS ALSO CAUSE HIGHER CURRENTS AND HIGHER THERMAL ENERGY AT THE CONTACT PINS OF THE MOTOR PROTECTION SWITCH. THIS FAILURE IS A KNOWN ISSUE. CORRECTIVE ACTIONS WERE DEFINED AND IMPLEMENTED. THE WIRING WAS REDESIGNED AND RELEASED. THE WIRING DESIGN USED AT THE TIME OF THIS EVENT IS UNKNOWN, THEREFORE, IT COULD NOT BE DETERMINED WHETHER THE CAPA PROJECT COULD BE ATTRIBUTED TO THIS COMPLAINT. IT IS RECOMMENDED, IF NOT ALREADY DONE, TO REPLACE THE WIRING AND THE MOTOR PROTECTION SWITCH IN BOTH STAGES.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE RED AND GREEN POWER SWITCH ON THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM WAS BURNT. REPLACEMENT OF THE POWER SWITCH WAS RECOMMENDED. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THE BIOMED CONFIRMED THE REPORTED EVENT. THE MOTOR PROTECTION SWITCH (MPS) IN STAGE 1 OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM WAS BURNT AND CHARRED. THE REPORTED ISSUE WAS DISCOVERED AT THE BEGINNING OF THE DAY. THE RO SYSTEM WAS ABLE TO POWER ON HOWEVER THE FACILITY STAFF NOTED THAT AN ERROR WAS RECEIVED RELATED TO DISRUPTION OF HEAT DISINFECTION (ERROR CODE NOT PROVIDED). NO SMOKE, SPARK, FLAME, OR ARCING WAS VISUALLY OBSERVED. THERE WERE NO POWER ISSUES OR ELECTRICAL STORMS ON OR AROUND THE REPORTED EVENT DATE. THE MPS WAS REPLACED TO RESOLVE THE THERMAL DAMAGE. A BLOWN 25-AMP FUSE WAS ALSO DISCOVERED IN THE EXTERNAL SERVICE DISCONNECT THAT WAS REPLACED. THE RO SYSTEM WAS RETURNED TO FULL SERVICE. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. NO PHOTOGRAPHS WERE AVAILABLE TO BE OBTAINED FOR REVIEW BY THE MANUFACTURER.

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 THE RED AND GREEN POWER SWITCH ON THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM WAS BURNT. REPLACEMENT OF THE POWER SWITCH WAS RECOMMENDED. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THE BIOMED CONFIRMED THE REPORTED EVENT. THE MOTOR PROTECTION SWITCH (MPS) IN STAGE 1 OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM WAS BURNT AND CHARRED. THE REPORTED ISSUE WAS DISCOVERED AT THE BEGINNING OF THE DAY. THE RO SYSTEM WAS ABLE TO POWER ON HOWEVER THE FACILITY STAFF NOTED THAT AN ERROR WAS RECEIVED RELATED TO DISRUPTION OF HEAT DISINFECTION (ERROR CODE NOT PROVIDED). NO SMOKE, SPARK, FLAME, OR ARCING WAS VISUALLY OBSERVED. THERE WERE NO POWER ISSUES OR ELECTRICAL STORMS ON OR AROUND THE REPORTED EVENT DATE. THE MPS WAS REPLACED TO RESOLVE THE THERMAL DAMAGE. A BLOWN 25-AMP FUSE WAS ALSO DISCOVERED IN THE EXTERNAL SERVICE DISCONNECT THAT WAS REPLACED. THE RO SYSTEM WAS RETURNED TO FULL SERVICE. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. NO PHOTOGRAPHS WERE AVAILABLE TO BE OBTAINED FOR REVIEW BY THE MANUFACTURER.