AQUABPLUS, B2, HF 1500 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 BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE BIOMED WAS CONTACTED BY THE FACILITY WHEN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM WOULD NOT START. THE BIOMED WENT ONSITE TO TROUBLESHOOT THE REPORTED ISSUE. THERE WAS THERMAL DAMAGE IDENTIFIED IN STAGE 1 AT THE CONNECTION BETWEEN THE POWER SUPPLY AND THE RED AND BLUE CABLE CONNECTOR (RUNNING TO THE MOTHERBOARD). THE BIOMED STATED THAT THE CONNECTION APPEARED CHARRED. THERE WAS ALSO DAMAGE TO THE POWER SUPPLY BOARD. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THERE WERE NO BLOWN FUSES IDENTIFIED IN THE EXTERNAL SERVICE DISCONNECT. THE HEATER RELAY DID NOT TRIP. THERE WERE NO LOCAL POWER GRID ISSUES OR REPORTED STORMS ON OR AROUND THE EVENT DATE. THE POWER SUPPLY AND CABLE CONNECTOR WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM WAS RETURNED TO FULL OPERATION. THERE WAS NO PATIENT INVOLVEMENT NOR HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE.

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER A PHOTOGRAPH WAS PROVIDED THAT WAS USED BY THE MANUFACTURER TO CONFIRM THE REPORTED ISSUE. THE CAUSE IS DETERMINED TO BE A BAD ELECTRICAL CONTACT AT THE CONTACT PIN WHICH RESULTS IN TRANSITION RESISTANCE AND HIGH THERMAL ENERGY. THIS RESULTS IN AN OVERHEATED AND DISCOLORED PART 24V CONNECTION CABLE/PLUG IN THIS CASE. DUE TO THE BAD ELECTRICAL CONTACT THE 24V VOLTAGE COULD GET LOST. THE FAILURE PATTERN IS KNOWN. CORRECTIVE ACTIONS WERE DEFINED AND IMPLEMENTED. THE PRODUCTION PROCESS WAS IMPROVED. DEVICES AND SPARE PARTS MANUFACTURED SINCE APRIL 2023 INCLUDED THE IMPROVED PROCESS. THE AFFECTED DEVICE WAS MANUFACTURED IN 2017 BEFORE IMPLEMENTING THE CORRECTIONS IN SERIES PRODUCTION. THE ISSUE WAS SOLVED BY REPLACING THE DAMAGED 24V CONNECTOR CABLE.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE BIOMED WAS CONTACTED BY THE FACILITY WHEN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM WOULD NOT START. THE BIOMED WENT ONSITE TO TROUBLESHOOT THE REPORTED ISSUE. THERE WAS THERMAL DAMAGE IDENTIFIED IN STAGE 1 AT THE CONNECTION BETWEEN THE POWER SUPPLY AND THE RED AND BLUE CABLE CONNECTOR (RUNNING TO THE MOTHERBOARD). THE BIOMED STATED THAT THE CONNECTION APPEARED CHARRED. THERE WAS ALSO DAMAGE TO THE POWER SUPPLY BOARD. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THERE WERE NO BLOWN FUSES IDENTIFIED IN THE EXTERNAL SERVICE DISCONNECT. THE HEATER RELAY DID NOT TRIP. THERE WERE NO LOCAL POWER GRID ISSUES OR REPORTED STORMS ON OR AROUND THE EVENT DATE. THE POWER SUPPLY AND CABLE CONNECTOR WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM WAS RETURNED TO FULL OPERATION. THERE WAS NO PATIENT INVOLVEMENT NOR HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE.