AQUABPLUS, B2, HF 2000 KIT

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS THAT THE STAGE 2 POWER SWITCH ON AN AQUABPLUS 2000 WAS TRIPPING. THE BIOMED SAID THE REVERSE OSMOSIS (RO) WAS IN DISINFECT MODE WHEN IT STARTED. THE MACHINE DISPLAYED A ¿W-02-50-20¿ (DISINFECTION STOPPED) ALARM CODE. THE BIOMED WAS EVENTUALLY ABLE TO COMPLETE THE DISINFECT AND THERE WERE NO FURTHER ISSUES. THE FOLLOWING DAY, BEFORE THE CLINIC HAD OPENED, THE RO STARTED TO TRIP AGAIN IN STAGE 2. THE BIOMED ARRIVED ONSITE TO FURTHER EVALUATE THE RO. THE BIOMED CHECKED THE LOCAL POWER SUPPLY AND CONFIRMED THERE WERE NO BLOWN FUSES. THE BIOMED ALSO CONFIRMED THE THERMAL OVERLOAD SWITCH WAS NOT TRIPPING. UPON FURTHER INSPECTION OF THE RO, THE BIOMED DISCOVERED THAT ONE OF THE CABLE LUGS CONNECTED TO THE MOTOR PROTECTION SWITCH (MPS) IN STAGE 2 WAS BURNT. THE BIOMED ALSO NOTICED A BURNING SMELL. THERE WERE NO SIGNS OF SMOKE, SPARKS, OR FLAMES. THE BIOMED WAS ABLE TO RUN THE RO IN EMERGENCY MODE 1 THAT DAY, WHILE AWAITING A REPLACEMENT POWER SWITCH. THE BIOMED REPLACED THE MPS AND THE BURNT CABLE THE FOLLOWING DAY. THE BIOMED DID NOT HAVE ANY PHOTOS OF THE DAMAGED CABLE, AND BOTH THE SWITCH AND THE CABLE HAD BEEN DISCARDED; NO SAMPLE WAS AVAILABLE FOR EVALUATION. THE BIOMED SAID THAT A STORM HAD COME THROUGH AROUND THE TIME OF THE EVENT, AND THE GENERATOR AT THE FACILITY KICKED ON. THE BIOMED SAID THIS COULD HAVE CONTRIBUTED TO THE POWER SWITCH TRIPPING. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

Additional Manufacturer Narrative

THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO PARTS WERE RETURNED FOR PHYSICAL EVALUATION. A REVIEW OF SIMILAR COMPLAINTS WAS NOT REQUIRED. HOWEVER, THE REPORTED EVENT CAN BE CONFIRMED BASED ON THE AVAILABLE INFORMATION. THE CAUSE OF THE THERMAL DAMAGE WAS BAD ELECTRICAL CONTACT AT THE MOTOR PROTECTION SWITCH (MPS). THE CABLE LUG CONNECTIONS AT THE MPS OVERHEATED FROM INCREASED CONTACT RESISTANCE AND THERE WAS AN INCREASE IN THERMAL ENERGY. THE MPS TRIPPED AS INTENDED AND OPERATION OF THE DEVICE WAS INTERRUPTED. THE FAILURE PATTERN IS A KNOWN ISSUE AND IS ADDRESSED IN A CAPA. AS A RESULT OF THE CAPA, A NEW WIRING DESIGN WAS RELEASED. ALTHOUGH THE MPS AND WIRING WERE REDESIGNED, THEY ARE NOT CURRENTLY AVAILABLE ON THE US MARKET. A REVIEW OF THE MACHINE FILES WAS NOT REQUIRED AS THIS WAS CONFIRMED TO BE A KNOWN ISSUE. ADDITIONALLY, A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS NOT REQUIRED. BASED ON THE INFORMATION PROVIDED AT INTAKE, THE REPORTED EVENT WAS CONFIRMED.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS THAT THE STAGE 2 POWER SWITCH ON AN AQUABPLUS 2000 WAS TRIPPING. THE BIOMED SAID THE REVERSE OSMOSIS (RO) WAS IN DISINFECT MODE WHEN IT STARTED. THE MACHINE DISPLAYED A ¿W-02-50-20¿ (DISINFECTION STOPPED) ALARM CODE. THE BIOMED WAS EVENTUALLY ABLE TO COMPLETE THE DISINFECT AND THERE WERE NO FURTHER ISSUES. THE FOLLOWING DAY, BEFORE THE CLINIC HAD OPENED, THE RO STARTED TO TRIP AGAIN IN STAGE 2. THE BIOMED ARRIVED ONSITE TO FURTHER EVALUATE THE RO. THE BIOMED CHECKED THE LOCAL POWER SUPPLY AND CONFIRMED THERE WERE NO BLOWN FUSES. THE BIOMED ALSO CONFIRMED THE THERMAL OVERLOAD SWITCH WAS NOT TRIPPING. UPON FURTHER INSPECTION OF THE RO, THE BIOMED DISCOVERED THAT ONE OF THE CABLE LUGS CONNECTED TO THE MOTOR PROTECTION SWITCH (MPS) IN STAGE 2 WAS BURNT. THE BIOMED ALSO NOTICED A BURNING SMELL. THERE WERE NO SIGNS OF SMOKE, SPARKS, OR FLAMES. THE BIOMED WAS ABLE TO RUN THE RO IN EMERGENCY MODE 1 THAT DAY, WHILE AWAITING A REPLACEMENT POWER SWITCH. THE BIOMED REPLACED THE MPS AND THE BURNT CABLE THE FOLLOWING DAY. THE BIOMED DID NOT HAVE ANY PHOTOS OF THE DAMAGED CABLE, AND BOTH THE SWITCH AND THE CABLE HAD BEEN DISCARDED; NO SAMPLE WAS AVAILABLE FOR EVALUATION. THE BIOMED SAID THAT A STORM HAD COME THROUGH AROUND THE TIME OF THE EVENT, AND THE GENERATOR AT THE FACILITY KICKED ON. THE BIOMED SAID THIS COULD HAVE CONTRIBUTED TO THE POWER SWITCH TRIPPING. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.