AQUABPLUS, B2, HF 1500 KIT

Additional Manufacturer Narrative

PLANT INVESTIGATION: THE MANUFACTURER WAS ABLE TO CONFIRM THE REPORTED ISSUE. THE COMPLAINT INVESTIGATION DETERMINED A BAD ELECTRICAL CONTACT INSIDE THE 24V PLUG AT THE POWER SUPPLY UNIT AS CAUSE FOR THE THERMAL DAMAGE AND DEVICE BREAKDOWN. THE FAILURE PATTERN ¿OVERHEATED WIRING OF 24V CONNECTOR AT THE POWER SUPPLY UNIT¿ IS RELATED TO THE MANUFACTURING PROCESS OF THE 24V CONNECTORS WHICH ARE CONNECTED TO THE POWER SUPPLY UNIT. THE INNER CONTACT WAS LIKELY DAMAGED OR DEFORMED DURING THE MANUFACTURING PROCESS. THIS CAN CAUSE A BAD ELECTRICAL CONTACT AT THE CONTACT PIN WHICH RESULTS IN TRANSITION RESISTANCE AND HIGH THERMAL ENERGY. THIS CAN RESULT IN OVERHEATED AND DISCOLORED ELECTRICAL CONNECTION/24V PLUG LIKE IN THIS CASE. THIS FAILURE IS A KNOWN ISSUE. CORRECTIVE ACTIONS WERE DEFINED AND IMPLEMENTED. THE PRODUCTION OF THESE COMPONENTS (24V PLUG) WAS OUTSOURCED TO A PROFESSIONAL SUPPLIER OF CRIMP AND WIRE CONNECTIONS TO IMPROVE THE PRODUCTION QUALITY. ACCORDING TO THE AVAILABLE INTAKE INFORMATION THE 24V PLUG CLEANED AND RECONNECTED TO SOLVE THE ISSUE. THE MANUFACTURER ALSO RECOMMENDED THE REPLACEMENT OF SPARE PART F40005870 (THE 24V PLUG). REVIEW OF THE DEVICE HISTORY RECORD OR SIMILAR COMPLAINTS IS NOT REQUIRED IN THIS CASE.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) AND AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DAMAGE WAS IDENTIFIED IN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM ON THE 24V CABLE CONNECTION THE POWER SUPPLY TO THE MOTHERBOARD IN STAGE 1. THE PLASTIC FROM THE CABLE HAD MELTED BETWEEN THE PINS WHICH PREVENTED A PROPERLY SECURED CONNECTION FROM BEING MADE. THE REPORTED ISSUE WAS DISCOVERED DURING MACHINE REPAIR. THE RO SYSTEM WAS INITIALLY PULLED FROM SERVICE FOR EVALUATION AFTER IT DID NOT POWER ON IN THE MORNING AS PROGRAMMED. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THERE WERE NO ALARM CODES ASSOCIATED WITH THE THERMAL DAMAGE. THE THERMAL OVERLOAD RELAY DID NOT TRIP. THERE WERE NO LOCAL POWER GRID ISSUES ON OR AROUND THE REPORTED EVENT DATE. THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. NO BLOWN FUSES WERE IDENTIFIED IN THE LOCAL POWER SUPPLY. TO RESOLVE THE ISSUE THE CONNECTION WAS PULLED AND THE MELTED PLASTIC WAS SCRAPED OFF IN ORDER TO MAKE A SECURE CONNECTION. THE RO SYSTEM WAS RETURNED TO SERVICE. A REPLACEMENT 24V WIRING HARNESS WILL BE ORDERED TO REPLACE THE CURRENT PART. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANYONE AS A RESULT OF DISCOVERING THE THERMAL DAMAGE. NO PARTS ARE CURRENTLY AVAILABLE TO BE 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

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) AND AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DAMAGE WAS IDENTIFIED IN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM ON THE 24V CABLE CONNECTION THE POWER SUPPLY TO THE MOTHERBOARD IN STAGE 1. THE PLASTIC FROM THE CABLE HAD MELTED BETWEEN THE PINS WHICH PREVENTED A PROPERLY SECURED CONNECTION FROM BEING MADE. THE REPORTED ISSUE WAS DISCOVERED DURING MACHINE REPAIR. THE RO SYSTEM WAS INITIALLY PULLED FROM SERVICE FOR EVALUATION AFTER IT DID NOT POWER ON IN THE MORNING AS PROGRAMMED. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THERE WERE NO ALARM CODES ASSOCIATED WITH THE THERMAL DAMAGE. THE THERMAL OVERLOAD RELAY DID NOT TRIP. THERE WERE NO LOCAL POWER GRID ISSUES ON OR AROUND THE REPORTED EVENT DATE. THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. NO BLOWN FUSES WERE IDENTIFIED IN THE LOCAL POWER SUPPLY. TO RESOLVE THE ISSUE THE CONNECTION WAS PULLED AND THE MELTED PLASTIC WAS SCRAPED OFF IN ORDER TO MAKE A SECURE CONNECTION. THE RO SYSTEM WAS RETURNED TO SERVICE. A REPLACEMENT 24V WIRING HARNESS WILL BE ORDERED TO REPLACE THE CURRENT PART. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANYONE AS A RESULT OF DISCOVERING THE THERMAL DAMAGE. NO PARTS ARE CURRENTLY AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.