AQUABPLUS, B2, HF 1000 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 USER FACILITY AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERE WERE INDICATIONS OF BURNT OR CHARRED WIRES WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE THERMAL DECOMPOSITION WAS DISCOVERED DURING AN EVALUATION AFTER THERE WAS INITIALLY NO DISPLAY ON THE RO SYSTEM. THE ATOM WAS ADVISED TO REPLACE THE 24V CABLE BETWEEN THE PCB AND MOTHERBOARD WHICH WAS DESCRIBED AS "BAD." PART NUMBERS WERE ALSO PROVIDED FOR THE POWER SUPPLY MOTHERBOARD CABLE AS WELL AS THE 7-METER POWER CORD, MOTOR PROTECTION SWITCH (MPS), AND MPS CONNECTION CABLE. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER A RESPONSE WAS NOT RECEIVED. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Description of Event or Problem

A USER FACILITY AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERE WERE INDICATIONS OF BURNT OR CHARRED WIRES WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE THERMAL DECOMPOSITION WAS DISCOVERED DURING AN EVALUATION AFTER THERE WAS INITIALLY NO DISPLAY ON THE RO SYSTEM. THE BIOMEDICAL TECHNICIAN NOTICED SOME DISCOLORATION ON BOTH SETS OF CONNECTING WIRES ON THE MOTOR PROTECTION SWITCH. THE ATOM WAS ADVISED TO REPLACE THE 24V CABLE BETWEEN THE PCB AND MOTHERBOARD WHICH WAS DESCRIBED AS "BAD." PART NUMBERS WERE ALSO PROVIDED FOR THE POWER SUPPLY MOTHERBOARD CABLE AS WELL AS THE 7-METER POWER CORD, MOTOR PROTECTION SWITCH (MPS), AND MPS CONNECTION CABLE. THE DISPLAY BEGAN WORKING THE PCB VOLTAGE MEASUREMENTS WERE CHECKED. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER A RESPONSE WAS NOT RECEIVED. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5 (EVENT DESCRIPTION), H6 (DEVICE COMPONENT CODE THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO SAMPLES WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER PHOTOGRAPHS WERE PROVIDED BY THE CUSTOMER WHICH WERE USED BY THE MANUFACTURER TO CONFIRM THE REPORTED ISSUE. THE LIKELY CAUSE OF THE REPORTED ISSUE IS POOR ELECTRICAL CONTACTING, WHICH LEADS TO INCREASED RESISTANCE AND THERMAL ENERGY THAT OVERHEATS AND DISCOLORS THE AFFECTED PARTS. THESE ARE KNOWN FAILURES. CORRECTIVE ACTIONS WERE DEFINED AND IMPLEMENTED. THE PARTS WERE REDESIGNED AND RELEASED. THE DEVICE WAS BUILT PRIOR TO THE RELEASE OF THE DESIGN IMPROVEMENTS THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD IS NOT REQUIRED. ACCORDING TO THE PROVIDED INFORMATION THE MOTOR PROTECTION SWITCH AND WIRING AS WELL AS THE 24V PLUG WERE REPLACED. IT IS UNKNOWN WHETHER THE PLUG WAS REPLACED, HOWEVER REPLACEMENT IS RECOMMENDED BY THE MANUFACTURER.

Description of Event or Problem

A USER FACILITY AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERE WERE INDICATIONS OF BURNT OR CHARRED WIRES WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE THERMAL DECOMPOSITION WAS DISCOVERED DURING AN EVALUATION AFTER THERE WAS INITIALLY NO DISPLAY ON THE RO SYSTEM. THE BIOMEDICAL TECHNICIAN NOTICED SOME DISCOLORATION ON BOTH SETS OF CONNECTING WIRES ON THE MOTOR PROTECTION SWITCH. THE ATOM WAS ADVISED TO REPLACE THE 24V CABLE BETWEEN THE PCB AND MOTHERBOARD WHICH WAS DESCRIBED AS "BAD." PART NUMBERS WERE ALSO PROVIDED FOR THE POWER SUPPLY MOTHERBOARD CABLE AS WELL AS THE 7-METER POWER CORD, MOTOR PROTECTION SWITCH (MPS), AND MPS CONNECTION CABLE. THE DISPLAY BEGAN WORKING THE PCB VOLTAGE MEASUREMENTS WERE CHECKED. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER A RESPONSE WAS NOT RECEIVED. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.