AQUABPLUS 2000 B2 1500

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. NO MACHINE FILES WERE MADE AVAILABLE FOR REVIEW. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT PERFORMED DUE TO THE AGE OF THE SYSTEM. THE MANUFACTURER CONFIRMED THE REPORTED EVENT BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER. HOWEVER, THE MANUFACTURER WAS UNABLE TO DETERMINE THE CAUSE FOR THE REPORTED ISSUE BASED ON THIS INFORMATION.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED THAT AN AQUABPLUS 2000 B2 1500 REVERSE OSMOSIS (RO) MACHINE POWERED OFF DURING A RINSE. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT. THE BIOMED SAID THE INCIDENT OCCURRED ON A DAY WHEN THE CLINIC WAS CLOSED FOR PATIENT TREATMENTS. THE BIOMED REACHED OUT TO TECHNICAL SUPPORT (TS) FOR TROUBLESHOOTING ASSISTANCE. AT FIRST THE BIOMED THOUGHT IT WAS THE MOTOR PROTECTION SWITCH (MPS) THAT CAUSED THE MACHINE TO TURN OFF. TS ADVISED THE BIOMED TO CHECK THE VOLTAGES INSIDE THE MACHINE, AND SOON THEY REALIZED THAT IT WAS A DIFFERENT PART CAUSING THE ISSUE. WHEN THE BIOMED TURNED THE RO BACK ON, THE RIGHT SIDE OF THE POWER CONTACTOR SPARKED. THERE WERE NO ALARM CODES DISPLAYED ON THE RO SYSTEM. THERE WAS NO BURNING SMELL. THERE WERE NO SIGNS OF SMOKE, FLAMES, OR THERMAL DECOMPOSITION. THE MOTOR PROTECTION SWITCH AND POWER CONTACTOR WERE NOT ORIGINAL TO THE MACHINE. THE BIOMED SAID THERE WERE NO FUSES THAT BLEW IN THE LOCAL POWER SUPPLY, AND THERE WERE NO KNOWN LOCAL POWER GRID ISSUES AROUND THE EVENT DATE. THE THERMAL OVERLOAD SWITCH HAD NOT TRIPPED. THE BIOMED WAS ABLE TO RESOLVE THE ISSUE BY REPLACING THE POWER CONTACTOR WHICH WAS STUCK IN THE DOWN POSITION. IT WAS NOTED THAT THE PUMP WAS NOT CONSTANTLY RUNNING AS A RESULT OF A STUCK CONTACTOR. THE BIOMED DID NOT HAVE FTP MACHINE FILES AND DID NOT KNOW HOW TO DOWNLOAD THEM. THE BIOMED PROVIDED PHOTOS OF THE FAULTY PART THAT WAS REPLACED. THE SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION, AS IT WAS DISCARDED.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED THAT AN AQUABPLUS 2000 B2 1500 REVERSE OSMOSIS (RO) MACHINE POWERED OFF DURING A RINSE. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT. THE BIOMED SAID THE INCIDENT OCCURRED ON A DAY WHEN THE CLINIC WAS CLOSED FOR PATIENT TREATMENTS. THE BIOMED REACHED OUT TO TECHNICAL SUPPORT (TS) FOR TROUBLESHOOTING ASSISTANCE. AT FIRST THE BIOMED THOUGHT IT WAS THE MOTOR PROTECTION SWITCH (MPS) THAT CAUSED THE MACHINE TO TURN OFF. TS ADVISED THE BIOMED TO CHECK THE VOLTAGES INSIDE THE MACHINE, AND SOON THEY REALIZED THAT IT WAS A DIFFERENT PART CAUSING THE ISSUE. WHEN THE BIOMED TURNED THE RO BACK ON, THE POWER CONTACTOR SPARKED. THERE WERE NO ALARM CODES DISPLAYED ON THE RO SYSTEM. THERE WAS NO BURNING SMELL. THERE WERE NO SIGNS OF SMOKE, FLAMES, OR THERMAL DECOMPOSITION. THE BIOMED SAID THERE WERE NO FUSES THAT BLEW IN THE LOCAL POWER SUPPLY, AND THERE WERE NO KNOWN LOCAL POWER GRID ISSUES AROUND THE EVENT DATE. THE THERMAL OVERLOAD SWITCH HAD NOT TRIPPED. THE BIOMED WAS ABLE TO RESOLVE THE ISSUE BY REPLACING THE POWER CONTACTOR WHICH WAS STUCK IN THE DOWN POSITION. THE BIOMED DID NOT HAVE FTP MACHINE FILES AND DID NOT KNOW HOW TO DOWNLOAD THEM. THE BIOMED PROVIDED PHOTOS OF THE FAULTY PART THAT WAS REPLACED. THE SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION, AS IT WAS DISCARDED.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5 (EVENT DESCRIPTION). 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 THAT AN AQUABPLUS 2000 B2 1500 REVERSE OSMOSIS (RO) MACHINE POWERED OFF DURING A RINSE. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT. THE BIOMED SAID THE INCIDENT OCCURRED ON A DAY WHEN THE CLINIC WAS CLOSED FOR PATIENT TREATMENTS. THE BIOMED REACHED OUT TO TECHNICAL SUPPORT (TS) FOR TROUBLESHOOTING ASSISTANCE. AT FIRST THE BIOMED THOUGHT IT WAS THE MOTOR PROTECTION SWITCH (MPS) THAT CAUSED THE MACHINE TO TURN OFF. TS ADVISED THE BIOMED TO CHECK THE VOLTAGES INSIDE THE MACHINE, AND SOON THEY REALIZED THAT IT WAS A DIFFERENT PART CAUSING THE ISSUE. WHEN THE BIOMED TURNED THE RO BACK ON, THE RIGHT SIDE OF THE POWER CONTACTOR SPARKED. THERE WERE NO ALARM CODES DISPLAYED ON THE RO SYSTEM. THERE WAS NO BURNING SMELL. THERE WERE NO SIGNS OF SMOKE, FLAMES, OR THERMAL DECOMPOSITION. THE MOTOR PROTECTION SWITCH AND POWER CONTACTOR WERE NOT ORIGINAL TO THE MACHINE. THE BIOMED SAID THERE WERE NO FUSES THAT BLEW IN THE LOCAL POWER SUPPLY, AND THERE WERE NO KNOWN LOCAL POWER GRID ISSUES AROUND THE EVENT DATE. THE THERMAL OVERLOAD SWITCH HAD NOT TRIPPED. THE BIOMED WAS ABLE TO RESOLVE THE ISSUE BY REPLACING THE POWER CONTACTOR WHICH WAS STUCK IN THE DOWN POSITION. IT WAS NOTED THAT THE PUMP WAS NOT CONSTANTLY RUNNING AS A RESULT OF A STUCK CONTACTOR. THE BIOMED DID NOT HAVE FTP MACHINE FILES AND DID NOT KNOW HOW TO DOWNLOAD THEM. THE BIOMED PROVIDED PHOTOS OF THE FAULTY PART THAT WAS REPLACED. THE SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION, AS IT WAS DISCARDED.