AQUABPLUS, B2, HF 2000 KIT

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 AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM ALARMED WITH ERROR CODE F-04-50-04 DURING THE T1 TEST AND THE MESSAGE ¿T1 TEST, PUMP P1 DEFECTIVE¿ WAS RECEIVED. THE BIOMED RESET THE STAGE 1 MOTOR PROTECTION SWITCH (MPS) WHICH CONTINUED TO TRIP UPON INITIATION OF THE T1 TEST. UPON EVALUATION THERMAL DECOMPOSITION WAS DISCOVERED ON THE L1 WIRE CONNECTION TO THE MPS. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. NO BLOWN FUSES WERE IDENTIFIED WITHIN THE EXTERNAL SERVICE DISCONNECT. THE HEATER RELAY DID NOT TRIP. NO LOCAL POWER GRID ISSUES NOR ELECTRICAL STORMS OCCURRED ON OR AROUND THE REPORTED EVENT DATE. THE BIOMED PLACED THE SYSTEM IN EMERGENCY MODE 2. REPLACEMENT PARTS WERE ORDERED FOR THE SWITCH AND THE MAIN POWER CABLES TO RESOLVE THE THERMAL DAMAGE IDENTIFIED ON L1. AT THE TIME OF FOLLOW-UP THE REPLACEMENT PARTS WERE PENDING ARRIVAL. THE BIOMED STATED THE PARTS WOULD BE INSTALLED AND THE SYSTEM WOULD BE RETURNED TO FULL OPERATION UPON RECEIVING THE REPLACEMENT PARTS. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE.

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER THE REPORTED ISSUE IS CONFIRMED BASED ON THE PROVIDED INFORMATION AND PHOTOGRAPH. THE CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE POOR ELECTRICAL CONTACTING ON THE CONNECTION PIN OF THE MOTOR PROTECTION SWITCH. HIGH CONTACT RESISTANCE AND THERMAL POWER LOSS WILL EXPOSE THE PARTS TO HIGHER TEMPERATURES RESULTING IN THE FOUND THERMAL DAMAGE. A DESIGN CHANGE FOR A DIFFERENT MOTOR PROTECTION SWITCH TYPE AND ELECTRICAL CONNECTION IS GOING TO BE IMPLEMENTED. THE NEW DESIGN IS CURRENTLY NOT AVAILABLE FOR THE US MARKET. THE DESIGN CHANGE PROCESS IS ONGOING. IT IS RECOMMENDED, IF NOT ALREADY DONE, TO REPLACE THE WIRING AND THE MOTOR PROTECTION SWITCH IN STAGE 1 AND STAGE 2.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM ALARMED WITH ERROR CODE F-04-50-04 DURING THE T1 TEST AND THE MESSAGE "T1 TEST, PUMP P1 DEFECTIVE" WAS RECEIVED. THE BIOMED RESET THE STAGE 1 MOTOR PROTECTION SWITCH (MPS) WHICH CONTINUED TO TRIP UPON INITIATION OF THE T1 TEST. UPON EVALUATION THERMAL DECOMPOSITION WAS DISCOVERED ON THE L1 WIRE CONNECTION TO THE MPS. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. NO BLOWN FUSES WERE IDENTIFIED WITHIN THE EXTERNAL SERVICE DISCONNECT. THE HEATER RELAY DID NOT TRIP. NO LOCAL POWER GRID ISSUES NOR ELECTRICAL STORMS OCCURRED ON OR AROUND THE REPORTED EVENT DATE. THE BIOMED PLACED THE SYSTEM IN EMERGENCY MODE 2. REPLACEMENT PARTS WERE ORDERED FOR THE SWITCH AND THE MAIN POWER CABLES TO RESOLVE THE THERMAL DAMAGE IDENTIFIED ON L1. AT THE TIME OF FOLLOW-UP THE REPLACEMENT PARTS WERE PENDING ARRIVAL. THE BIOMED STATED THE PARTS WOULD BE INSTALLED AND THE SYSTEM WOULD BE RETURNED TO FULL OPERATION UPON RECEIVING THE REPLACEMENT PARTS. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE.