AQUABPLUS, B2, HF 1500 KIT

Description of Event or Problem

THE BIOMEDICAL TECHNICIAN (BIOMED) FOR A USER FACILITY REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERE WERE INDICATIONS OF BURNT WIRING IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE SEVERITY OF THE THERMAL DECOMPOSITION AND DESCRIPTION OF THE AFFECTED PARTS WAS NOT PROVIDED. THE REPORTED ISSUE WAS DISCOVERED DURING MACHINE EVALUATION. THE RO SYSTEM ALARMED DURING THE T1 TEST WITH ERROR CODE "F-04-50-04: T1 TEST. PUMP P1 DEFECTIVE." THE MOTOR PROTECTION SWITCH (MPS) HAD ALREADY BEEN REPLACED AND THE RO SYSTEM WAS OPERATING IN EMERGENCY MODE UPON INITIAL REPORTING. THE CUSTOMER WAS ADVISED TO RESET THE THERMAL OVERLOAD RELAY, REPLACE THE CONNECTING CABLES FROM THE MPS TO THE CONTACTOR, AND REPLACE THE 20 AMP FUSE. THERE WAS NO PATIENT INVOLVEMENT AND NO REPORTED HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THIS ISSUE. 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: B3 (DATE OF EVENT) THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

Additional Manufacturer Narrative

PLANT INVESTIGATION: THE COMPLAINT SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER THE REPORTED THERMAL DAMAGE WAS CONFIRMED BY THE MANUFACTURER WITH THE PROVIDED INTAKE INFORMATION. THE MOST LIKELY CAUSE FOR THE FAILURE PATTERN IS A BAD ELECTRICAL CONTACT AT THE MOTOR PROTECTION SWITCH. THE CONTACT RESISTANCE AND PUMP CURRENT INCREASED WHICH LED TO INCREASED THERMAL ENERGY AT THE CONTACTS POINTS RESULTING IN OVERHEATED AND DISCOLORED CABLE LUGS AT THE MOTOR PROTECTION SWITCH. THE MOTOR PROTECTION SWITCH WAS LOADED UNBALANCED AND TRIPPED, TRIGGERING ALARM ERROR F-04-51-04 AND INTERRUPTING DEVICE OPERATION. IT SHOULD ALSO BE NOTED THAT POWER SURGES/FLUCTUATIONS HAVE A CONTRIBUTING FACTOR TO THIS FAILURE PATTERN. THIS FAILURE IS A KNOWN ISSUE. CORRECTIVE ACTIONS WERE DEFINED AND IMPLEMENTED. AN IMPROVEMENT TO THE WIRING DESIGN WAS CREATED BUT HAS NOT BEEN RELEASED FOR THE US MARKET. IT IS RECOMMENDED TO REPLACE THE WIRING AND MOTOR PROTECTION SWITCH IN STAGE 1 AND STAGE 2 TO PREVENT ADDITIONAL FAILURES. FURTHERMORE, IT IS RECOMMENDED TO REPLACE THE FUSES IN THE LOCAL POWER SUPPLY EVERY 24 MONTHS.

Description of Event or Problem

THE BIOMEDICAL TECHNICIAN (BIOMED) FOR A USER FACILITY REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERE WERE INDICATIONS OF BURNT WIRING IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE SEVERITY OF THE THERMAL DECOMPOSITION AND DESCRIPTION OF THE AFFECTED PARTS WAS NOT PROVIDED. THE REPORTED ISSUE WAS DISCOVERED DURING MACHINE EVALUATION. THE RO SYSTEM ALARMED DURING THE T1 TEST WITH ERROR CODE "F-04-50-04: T1 TEST. PUMP P1 DEFECTIVE." THE MOTOR PROTECTION SWITCH (MPS) HAD ALREADY BEEN REPLACED AND THE RO SYSTEM WAS OPERATING IN EMERGENCY MODE UPON INITIAL REPORTING. THE CUSTOMER WAS ADVISED TO RESET THE THERMAL OVERLOAD RELAY, REPLACE THE CONNECTING CABLES FROM THE MPS TO THE CONTACTOR, AND REPLACE THE 20 AMP FUSE. THERE WAS NO PATIENT INVOLVEMENT AND NO REPORTED HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THIS ISSUE. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER A RESPONSE WAS NOT RECEIVED. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

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 THERE WERE INDICATIONS OF BURNT WIRING IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE SEVERITY OF THE THERMAL DECOMPOSITION AND DESCRIPTION OF THE AFFECTED PARTS WAS NOT PROVIDED. THE REPORTED ISSUE WAS DISCOVERED DURING MACHINE EVALUATION. THE RO SYSTEM ALARMED DURING THE T1 TEST WITH ERROR CODE "F-04-50-04: T1 TEST. PUMP P1 DEFECTIVE." THE MOTOR PROTECTION SWITCH (MPS) HAD ALREADY BEEN REPLACED AND THE RO SYSTEM WAS OPERATING IN EMERGENCY MODE UPON INITIAL REPORTING. THE CUSTOMER WAS ADVISED TO RESET THE THERMAL OVERLOAD RELAY, REPLACE THE CONNECTING CABLES FROM THE MPS TO THE CONTACTOR, AND REPLACE THE 20 AMP FUSE. THERE WAS NO PATIENT INVOLVEMENT AND NO REPORTED HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THIS ISSUE. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER A RESPONSE WAS NOT RECEIVED. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.