AQUABPLUS, B2, HF 1500 KIT

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS THAT THE STAGE 1 MOTOR PROTECTION SWITCH (MPS) ON AN AQUABPLUS 1500 WAS TRIPPING. THE BIOMED SAID THE REVERSE OSMOSIS (RO) WOULD NOT POWER ON IN THE MORNING, BEFORE THE CLINIC OPENED. WHEN THEY TRIED TURNING IT ON, IT KEPT TURNING OFF. AFTER SEVERAL CYCLES THEY WERE ABLE TO POWER IT ON AND IT STAYED ON. THE BIOMED SAID THEY LUCKILY MADE IT THROUGH THE ENTIRE DAY WITHOUT IT TURNING OFF. THE BIOMED DID NOT RECALL ANY ALARM CODES THAT WERE SHOWING. AT THE END OF THE DAY, THE BIOMED FURTHER EVALUATED THE RO AND DISCOVERED MULTIPLE BURNT CABLES GOING TO THE MPS IN STAGE 1. THE BIOMED DID NOT REMEMBER HOW MANY CABLES WERE BURNT, BUT CONFIRMED IT WAS MORE THAN ONE. THERE WAS NO BURNING SMELL, AND THERE WERE NO SIGNS OF SMOKE, SPARKS, OR FLAMES. THE BIOMED REPLACED THE MPS AND CONNECTED CABLES, AND THIS RESOLVED THE REPORTED ISSUE. THE BIOMED CONFIRMED THERE WERE NO BLOWN FUSES IN THE LOCAL POWER SUPPLY. THE BIOMED ALSO CONFIRMED THE THERMAL OVERLOAD SWITCH WAS NOT TRIPPING. THE BIOMED DID NOT HAVE ANY PHOTOS OF THE DAMAGED CABLES, AND BOTH THE SWITCH AND CABLES HAD BEEN DISCARDED; NO SAMPLE WAS AVAILABLE FOR EVALUATION. THE BIOMED SAID THERE WERE NO KNOWN POWER GRID ISSUES AROUND THE TIME OF THE EVENT. HOWEVER, THEY DID SAY THAT THE FACILITY HAS FREQUENT POWER OUTAGES, AND THEY DON¿T HAVE A GENERATOR. 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 AND OPERATION OF THE DEVICE WAS INTERRUPTED. NO PHOTOS WERE AVAILABLE FOR REVIEW. BASED ON THE INFORMATION PROVIDED AT INTAKE, THE WIRING DESIGN IS UNKNOWN. THE MANUFACTURER SUSPECTS THAT THE OLD WIRING DESIGN (WITH YELLOW CABLE LUGS) WAS USED, AGAINST THE MANUFACTURER¿S RECOMMENDATIONS. THE FAILURE PATTERN DUE TO THE OLD WIRING DESIGN 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 COULD NOT BE PERFORMED AS THE FILES WERE NOT PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS NOT REQUIRED DUE TO THE FAILURE PATTERN BEING A KNOWN ISSUE. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT WAS CONFIRMED.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS THAT THE STAGE 1 MOTOR PROTECTION SWITCH (MPS) ON AN AQUABPLUS 1500 WAS TRIPPING. THE BIOMED SAID THE REVERSE OSMOSIS (RO) WOULD NOT POWER ON IN THE MORNING, BEFORE THE CLINIC OPENED. WHEN THEY TRIED TURNING IT ON, IT KEPT TURNING OFF. AFTER SEVERAL CYCLES THEY WERE ABLE TO POWER IT ON AND IT STAYED ON. THE BIOMED SAID THEY LUCKILY MADE IT THROUGH THE ENTIRE DAY WITHOUT IT TURNING OFF. THE BIOMED DID NOT RECALL ANY ALARM CODES THAT WERE SHOWING. AT THE END OF THE DAY, THE BIOMED FURTHER EVALUATED THE RO AND DISCOVERED MULTIPLE BURNT CABLES GOING TO THE MPS IN STAGE 1. THE BIOMED DID NOT REMEMBER HOW MANY CABLES WERE BURNT, BUT CONFIRMED IT WAS MORE THAN ONE. THERE WAS NO BURNING SMELL, AND THERE WERE NO SIGNS OF SMOKE, SPARKS, OR FLAMES. THE BIOMED REPLACED THE MPS AND CONNECTED CABLES, AND THIS RESOLVED THE REPORTED ISSUE. THE BIOMED CONFIRMED THERE WERE NO BLOWN FUSES IN THE LOCAL POWER SUPPLY. THE BIOMED ALSO CONFIRMED THE THERMAL OVERLOAD SWITCH WAS NOT TRIPPING. THE BIOMED DID NOT HAVE ANY PHOTOS OF THE DAMAGED CABLES, AND BOTH THE SWITCH AND CABLES HAD BEEN DISCARDED; NO SAMPLE WAS AVAILABLE FOR EVALUATION. THE BIOMED SAID THERE WERE NO KNOWN POWER GRID ISSUES AROUND THE TIME OF THE EVENT. HOWEVER, THEY DID SAY THAT THE FACILITY HAS FREQUENT POWER OUTAGES, AND THEY DON¿T HAVE A GENERATOR. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.