AQUABPLUS, B2, HF 2000 KIT

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) CONTACTED FRESENIUS TECHNICAL SUPPORT AND REPORTED THAT THE STAGE 1 MOTOR PROTECTION SWITCH (MPS) FROM AN AQUABPLUS 2000 TRIPPED. TROUBLESHOOTING LED TO THE THERMAL OVERLOAD BEING RESET. IT WAS REPORTED THAT THERE WERE STORMS IN THE AREA AROUND THE TIME OF THE EVENT. THE BIOMED ALSO STATED THAT L3 WAS MISSING VOLTAGE, AND THE EXTERNAL POWER SUPPLY WAS RESET. UPON FURTHER INSPECTION, IT WAS DETERMINED THAT THE MPS WAS FAULTY ON LEG 3. THE BIOMED ALSO INDICATED THAT THE L1 CABLE FROM THE MPS TO THE CONTACTOR WAS BURNT OR CHARRED. THE BIOMED SAID THEY WERE ABLE TO ACTIVATE EMERGENCY MODE 2. NO FURTHER DETAILS WERE PROVIDED IN THE INITIAL REPORTING. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, AND THUS FAR NO FURTHER DETAILS HAVE BEEN PROVIDED. INDICATIONS OF BURNT OR CHARRED WIRES? YES PATIENT INVOLVEMENT? YES.

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 TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE FAILURE PATTERN IS A KNOWN ISSUE AND IS ADDRESSED IN A CAPA. CORRECTIVE ACTIONS OUT OF THE CAPA PROJECT WERE DEFINED AND IMPLEMENTED, AND THE DESIGN OF THE CRIMPED CABLE LUG HAS BEEN CHANGED. HOWEVER, THIS DEVICE WAS BUILT BEFORE IMPLEMENTATION OF THE CAPA AND WAS STILL EQUIPPED WITH THE OLD DESIGN OF THE CRIMPED CABLE LUG AT THE TIME OF THE FAILURE. IT IS UNKNOWN IF ANY PARTS WERE REPLACED AS ADDITIONAL INFORMATION COULD NOT BE OBTAINED, DESPITE MULTIPLE FOLLOW-UP ATTEMPTS BEING PERFORMED. A REVIEW OF SIMILAR COMPLAINTS WAS NOT REQUIRED IN THIS CASE. THE COMPLAINT AND REPORTED DEFICIENCY WAS ABLE TO BE CONFIRMED BY MEANS OF THE INITIALLY PROVIDED INFORMATION. THE COMPLAINT INVESTIGATION CONSIDERED THE FOLLOWING RELEVANT INFORMATION: (1) THE MOTOR PROTECTION SWITCH (MPS) AND THERMAL OVERLOAD SWITCH AT STAGE 1 HAD TRIPPED, (2) THE MAINS PHASE L3 WAS MISSING AND THE EXTERNAL/LOCAL POWER SUPPLY WAS RESET, (3) STORMS (AND THEREFORE POWER SURGE(S) AND/OR LINE FLUCTUATIONS) WERE REPORTED AROUND THE TIME OF THE EVENT, AND (4) THE L1 CABLE FROM THE MPS TO CONTACTOR DISPLAYED SIGNS OF THERMAL DAMAGE. INVESTIGATION OF MACHINE FILES WAS FOUND TO BE UNNECESSARY. THE COMPLAINT INTAKE INFORMATION WAS SUFFICIENT TO DETERMINE THE FAILURE CAUSE(S). BASED ON THE INFORMATION AVAILABLE, THE REPORTED EVENT WAS CONFIRMED.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) CONTACTED FRESENIUS TECHNICAL SUPPORT AND REPORTED THAT THE STAGE 1 MOTOR PROTECTION SWITCH (MPS) FROM AN AQUABPLUS 2000 TRIPPED. TROUBLESHOOTING LED TO THE THERMAL OVERLOAD BEING RESET. IT WAS REPORTED THAT THERE WERE STORMS IN THE AREA AROUND THE TIME OF THE EVENT. THE BIOMED ALSO STATED THAT L3 WAS MISSING VOLTAGE, AND THE EXTERNAL POWER SUPPLY WAS RESET. UPON FURTHER INSPECTION, IT WAS DETERMINED THAT THE MPS WAS FAULTY ON LEG 3. THE BIOMED ALSO INDICATED THAT THE L1 CABLE FROM THE MPS TO THE CONTACTOR WAS BURNT OR CHARRED. THE BIOMED SAID THEY WERE ABLE TO ACTIVATE EMERGENCY MODE 2. NO FURTHER DETAILS WERE PROVIDED IN THE INITIAL REPORTING. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, AND THUS FAR NO FURTHER DETAILS HAVE BEEN PROVIDED.

Additional Manufacturer Narrative

CORRECTION: B5 - THE INITIAL MDR INADVERTENTLY STATED THAT THERE WAS PATIENT INVOLVEMENT 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) CONTACTED FRESENIUS TECHNICAL SUPPORT AND REPORTED THAT THE STAGE 1 MOTOR PROTECTION SWITCH (MPS) FROM AN AQUABPLUS 2000 TRIPPED. TROUBLESHOOTING LED TO THE THERMAL OVERLOAD BEING RESET. IT WAS REPORTED THAT THERE WERE STORMS IN THE AREA AROUND THE TIME OF THE EVENT. THE BIOMED ALSO STATED THAT L3 WAS MISSING VOLTAGE, AND THE EXTERNAL POWER SUPPLY WAS RESET. UPON FURTHER INSPECTION, IT WAS DETERMINED THAT THE MPS WAS FAULTY ON LEG 3. THE BIOMED ALSO INDICATED THAT THE L1 CABLE FROM THE MPS TO THE CONTACTOR WAS BURNT OR CHARRED. THE BIOMED SAID THEY WERE ABLE TO ACTIVATE EMERGENCY MODE 2. NO FURTHER DETAILS WERE PROVIDED IN THE INITIAL REPORTING. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, AND THUS FAR NO FURTHER DETAILS HAVE BEEN PROVIDED.