AQUABPLUS, B2, HF 1500 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 BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE BIOMED WAS CALLED ONSITE AFTER THE RO SYSTEM SUDDENLY STOPPED WORKING. THE T1 TEST WAS STARTED AND TWO ERRORS CODES RELATING TO THE P1 PUMP AND HIGH CONCENTRATE PRESSURE WERE ENCOUNTERED, HOWEVER THE EXACT ERROR CODES OR MESSAGES COULD NOT BE PROVIDED. THE BIOMED LOOSENED THE SCREWS ON THE STAGE 1 HOOD TO FIND THE MOTOR PROTECTION SWITCH (MPS) HAD TRIPPED AND RESET IT. THE PUMP MOMENTARILY CAME ON BEFORE THE MPS TRIPPED AGAIN. UPON EVALUATION, THERMAL DAMAGE TO THE MPS WAS IDENTIFIED. THE MPS APPEARED BURNED AND THE CONNECTED POWER CONTACTOR CABLE WAS MELTED. TO RESOLVE THE REPORTED THERMAL DAMAGE, THE MPS WAS REPLACED WITH AN AVAILABLE SPARE AND THE THERMAL DAMAGE WAS TRIMMED OFF THE POWER CONTACTOR CABLE AND REPLACED WITH NEW (THIRD-PARTY) SPADE CONNECTORS. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THERE WERE NO BLOWN FUSES IDENTIFIED IN THE EXTERNAL SERVICE DISCONNECT. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. THE BIOMED NOTED THE CLINIC IS BASED IN THE WING OF A HOSPITAL THAT IS LOCATED ON AN ISLAND WITHIN ONE MILE OF THE OCEAN (IN HILTON HEAD, SC). STORMS OCCUR IN THE AREA AND THERE IS NO GENERATOR FOR THE CLINIC SO POWER SURGES ARE NOT UNCOMMON. DESPITE THE CLINIC LOCATION, THE BIOMED DID NOT REPORT ANY RECENT STORMS OF LOCAL POWER GRID ISSUES THAT WOULD¿VE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. NO PARTS WERE REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Description of Event or Problem

A BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE BIOMED WAS CALLED ONSITE AFTER THE RO SYSTEM SUDDENLY STOPPED WORKING. THE T1 TEST WAS STARTED AND TWO ERRORS CODES RELATING TO THE P1 PUMP AND HIGH CONCENTRATE PRESSURE WERE ENCOUNTERED, HOWEVER THE EXACT ERROR CODES OR MESSAGES COULD NOT BE PROVIDED. THE BIOMED LOOSENED THE SCREWS ON THE STAGE 1 HOOD TO FIND THE MOTOR PROTECTION SWITCH (MPS) HAD TRIPPED AND RESET IT. THE PUMP MOMENTARILY CAME ON BEFORE THE MPS TRIPPED AGAIN. UPON EVALUATION, THERMAL DAMAGE TO THE MPS WAS IDENTIFIED. THE MPS APPEARED BURNED AND THE CONNECTED POWER CONTACTOR CABLE WAS MELTED. TO RESOLVE THE REPORTED THERMAL DAMAGE, THE MPS WAS REPLACED WITH AN AVAILABLE SPARE AND THE THERMAL DAMAGE WAS TRIMMED OFF THE POWER CONTACTOR CABLE AND REPLACED WITH NEW (THIRD-PARTY) SPADE CONNECTORS. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THERE WERE NO BLOWN FUSES IDENTIFIED IN THE EXTERNAL SERVICE DISCONNECT. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. THE BIOMED NOTED THE CLINIC IS BASED IN THE WING OF A HOSPITAL THAT IS LOCATED ON AN ISLAND WITHIN ONE MILE OF THE OCEAN (IN HILTON HEAD, SC). STORMS OCCUR IN THE AREA AND THERE IS NO GENERATOR FOR THE CLINIC SO POWER SURGES ARE NOT UNCOMMON. DESPITE THE CLINIC LOCATION, THE BIOMED DID NOT REPORT ANY RECENT STORMS OF LOCAL POWER GRID ISSUES THAT WOULD¿VE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. NO PARTS WERE REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER THE REPORTED EVENT CAN BE CONFIRMED FROM THE PHOTOGRAPH PROVIDED UPON INTAKE. THE REPORTED EVENT CAN BE ATTRIBUTED 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 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. THE MOTOR PROTECTION SWITCH THEN TRIPPED AND INTERRUPTED DEVICE OPERATION. THIS FAILURE IS A KNOWN ISSUE. CORRECTIVE ACTIONS HAVE BEEN DEFINED. A NEW DESIGN OF THE MOTOR PROTECTION SWITCH AND ITS WIRING HAS BEEN DEVELOPED, BUT IS CURRENTLY NOT RELEASED FOR THE US MARKET. ACCORDING TO THE PROVIDED INFORMATION, THE ISSUE WAS RESOLVED BY REPLACING THE MOTOR PROTECTION SWITCH WAS AND CUTTING THE DAMAGED WIRES AND FITTING THEM WITH THIRD-PARTY CABLE LUGS. IT IS NOT RECOMMENDED TO USE THIRD-PARTY PARTS FOR ANY KIND OF REPAIRS. THE MANUFACTURER RECOMMENDS USING ONLY THE ORIGINAL SPARE PARTS. IT IS HIGHLY RECOMMENDED TO REPLACE THE WIRING AGAINST THE OFFICIAL SPARE PART.