AQUABPLUS, B2, HF 1000 KIT

Description of Event or Problem

THE BIOMEDICAL TECHNICIAN (BIOMED) FOR A USER FACILITY REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. CHARRED WIRING WAS IDENTIFIED BETWEEN THE POWER SUPPLY AND THE MOTHERBOARD AND THE MOTOR PROTECTION SWITCH (MPS) AND CONTACTOR. VOLTAGE WAS CONFIRMED AMONG ALL THREE LEGS TO THE MPS. THE MPS WAS REPLACED. THE POWER SUPPLY AND 24V CABLE FROM STAGE 2 WERE INSTALLED INTO STAGE 1 IN ORDER TO RETURN THE RO SYSTEM TO SERVICE. THE RO SYSTEM PASSED THE T1 TEST. PART NUMBERS FOR THE MPS (F50005352), POWER CABLE (F50005232), CABLE MPS TO CONTACTOR (F50005347), AND 24V CABLE (F40005871) WERE PROVIDED. THERE WAS NO REPORTED HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER A RESPONSE WAS NOT RECEIVED.

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER, THE REPORTED THERMAL DAMAGE CAN BE CONFIRMED FROM THE PROVIDED INTAKE INFORMATION AND PHOTOGRAPHS. THERMAL DAMAGE ON THE 24 VDC CONNECTOR AT THE POWER SUPPLY UNIT WAS CAUSED FROM BAD ELECTRICAL CONTACTING. A BAD ELECTRICAL CONTACT AT A PIN OF THE 24 VDC CONNECTOR RESULTS IN A HIGH TRANSITION RESISTANCE AND HIGH THERMAL ENERGY CAUSING THE REPORTED THERMAL DAMAGE ON THE CONNECTOR. DUE TO THE BAD ELECTRICAL CONTACTING AT THE PIN, THE 24 VDC POWER WAS LOST AND THE DISPLAY WAS OFF, AS THE DISPLAY IS POWERED VIA THE 24 VDC CONNECTION. THIS FAILURE IS A KNOWN ISSUE. CORRECTIVE ACTIONS WERE DEFINED AND IMPLEMENTED. AN IMPROVEMENT TO THE MANUFACTURING PROCESS OF THE 24 VDC CABLE/CONNECTOR WAS IMPLEMENTED IN PRODUCTION IN APRIL 2023. THIS DEVICE WAS MANUFACTURED IN 2020 PRIOR TO THE MANUFACTURING PROCESS CHANGE OF THE 24 VDC CABLE/CONNECTOR. ACCORDING THE AVAILABLE INFORMATION, THE 24 VDC CABLE/CONNECTOR WAS REPLACED TO RESOLVE THIS ISSUE AND THE DISPLAY BECAME FUNCTIONAL AGAIN. THE SECOND IDENTIFIED INSTANCE OF THERMAL DAMAGE ON THE CABLE LUG/S AT MOTOR PROTECTION SWITCH ALSO RESULTED FROM BAD ELECTRICAL CONTACTING. LOW CONTACT PRESSURE RESULTED IN HIGH CONTACT RESISTANCE AT THE BAD CONTACTED POINT AND A HIGH THERMAL POWER LOSS AT THE BAD CONTACTING CONNECTIONS. AS HIGHER CURRENTS OCCUR IN SUCH A SCENARIO, THE WIRES AND CABLE LUGS ARE EXPOSED TO HIGHER TEMPERATURES RESPECTIVELY, RESULTING IN THE REPORTED THERMAL DAMAGE. THIS FAILURE PATTERN IS ALSO A KNOWN ISSUE. CORRECTIVE ACTIONS WERE DEFINED AND IMPLEMENTED. THE DESIGN OF THE CRIMPED CABLE LUG WAS CHANGED AND RELEASED. THE PROVIDED INTAKE INFORMATION STATES THAT THE MOTOR PROTECTION SWITCH AND WIRING BETWEEN THE MOTOR PROTECTION SWITCH AND THE CONTACTOR AT STAGE 1 WERE REPLACED. IT IS RECOMMENDED TO REPLACE THE POWER CORD WIRING AT STAGE 1 AS WELL AS STAGE 2, IF NECESSARY, WITH THE NEW AVAILABLE DESIGN.

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

THE BIOMEDICAL TECHNICIAN (BIOMED) FOR A USER FACILITY REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. CHARRED WIRING WAS IDENTIFIED BETWEEN THE POWER SUPPLY AND THE MOTHERBOARD AND THE MOTOR PROTECTION SWITCH (MPS) AND CONTACTOR. VOLTAGE WAS CONFIRMED AMONG ALL THREE LEGS TO THE MPS. THE MPS WAS REPLACED. THE POWER SUPPLY AND 24V CABLE FROM STAGE 2 WERE INSTALLED INTO STAGE 1 IN ORDER TO RETURN THE RO SYSTEM TO SERVICE. THE RO SYSTEM PASSED THE T1 TEST. PART NUMBERS FOR THE MPS (F50005352), POWER CABLE (F50005232), CABLE MPS TO CONTACTOR (F50005347), AND 24V CABLE (F40005871) WERE PROVIDED. THERE WAS NO REPORTED HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER A RESPONSE WAS NOT RECEIVED.