AQUABPLUS, B2, HF 2000 KIT
Received Dec 1, 2023 · Event occurred Nov 13, 2023
Report 3010850471-2023-00102 · MDR key 18251929
Device
Product problems
- Thermal Decomposition of Device
- Thermal Decomposition of Device
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE THERE WAS NO POWER GOING TO THE DISPLAY OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE BIOMED VERIFIED VOLTAGE OUTPUT FROM THE SWITCH TO THE RO SYSTEM. DURING TROUBLESHOOTING THE BIOMED DISCOVERED THAT THE 24V CABLE AND THE X9 CONNECTOR ON THE MOTHERBOARD IN STAGE 1 WERE BURNED. THE BIOMED WAS INSTRUCTED TO BORROW THE CABLE FROM STAGE 2. AFTER SWAPPING THE CABLE THE DISPLAY LIT UP AND EVERYTHING STARTED UP AS EXPECTED. THE RO SYSTEM WAS RETURNED TO SERVICE AND THE BIOMED WAS INSTRUCTED TO ORDER REPLACEMENT PARTS. THERE WAS NO PATIENT INVOLVEMENT NOR REPORTED PERSONAL HARM TO ANY INDIVIDUAL AS A RESULT OF THE THERMAL DAMAGE. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER A RESPONSE WAS NOT RECEIVED. NO SAMPLES WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.
Additional Manufacturer Narrative
PLANT INVESTIGATION: NO SAMPLES WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE COMPLAINT AND THE REPORTED DEFICIENCY CAN BE CONFIRMED BY MEANS OF THE COMPLAINT INTAKE INFORMATION. THE BAD ELECTRICAL CONTACT AT THE CONTACT PIN WAS DETERMINED TO BE THE CAUSE OF THE REPORTED ISSUE. THE BAD ELECTRICAL CONNECTION RESULTS IN TRANSITION RESISTANCE AND HIGH THERMAL ENERGY WHICH CAUSED THE OVERHEATED AND DISCOLORED ELECTRICAL CONNECTION/24V PLUG. THIS FAILURE PATTERN IS KNOWN. CORRECTIVE ACTIONS WERE DEFINED AND IMPLEMENTED. THE DESIGN OF THE 24 CONNECTORS TO THE POWER SUPPLY UNIT WERE CHANGED. THE AFFECTED DEVICE WAS BUILT BEFORE THE IMPLEMENTATION OF THE CAPA AND WAS STILL EQUIPPED WITH THE OLD DESIGN AT TIME OF THE FAILURE. THE MANUFACTURER RECOMMENDS, IF NOT ALREADY DONE, TO REPLACE THE CONNECTION CABLE IN BOTH STAGE 1 AND STAGE 2.
Description of Event or Problem
A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE THERE WAS NO POWER GOING TO THE DISPLAY OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE BIOMED VERIFIED VOLTAGE OUTPUT FROM THE SWITCH TO THE RO SYSTEM. DURING TROUBLESHOOTING THE BIOMED DISCOVERED THAT THE 24V CABLE AND THE X9 CONNECTOR ON THE MOTHERBOARD IN STAGE 1 WERE BURNED. THE BIOMED WAS INSTRUCTED TO BORROW THE CABLE FROM STAGE 2. AFTER SWAPPING THE CABLE THE DISPLAY LIT UP AND EVERYTHING STARTED UP AS EXPECTED. THE RO SYSTEM WAS RETURNED TO SERVICE AND THE BIOMED WAS INSTRUCTED TO ORDER REPLACEMENT PARTS. THERE WAS NO PATIENT INVOLVEMENT NOR REPORTED PERSONAL HARM TO ANY INDIVIDUAL AS A RESULT OF THE THERMAL DAMAGE. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER A RESPONSE WAS NOT RECEIVED. NO SAMPLES 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.