AQUAA 1800 A2 1800H
Received Jan 14, 2026 · Event occurred Dec 16, 2025
Report 3010850471-2026-00002 · MDR key 24067872
Device
Product problems
- Sparking
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE BIOMEDICAL TECHNICIAN (BIOMED) FOR A USER FACILITY REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE AQUAA REVERSE OSMOSIS (RO) SYSTEM ALARMED WITH ERROR CODE "F¿01¿04¿01 FAILURE: HTU BK I/O BUS FAILURE." THE BIOMED STATED UPON INITIAL FOLLOW-UP THAT THE HT IS BLOWING A 2-AMP BUS FUSE AT F5. THE PART WAS THERMALLY DAMAGED AND UPON FURTHER FOLLOW-UP IT WAS REPORTED THAT SPARKING OCCURRED WHEN ATTEMPTING TO REPLACE THE PART. THE BIOMED TRACED THE CAUSE TO THE PT-5 SENSOR. THE FUSE AND PT-5 SENSOR WERE REPLACED TO RESOLVE THE REPORTED ISSUES. THE SYSTEM WAS RETURNED TO FULL SERVICE FOLLOWING REPAIR. NO PARTS WERE RETURNED TO THE MANUFACTURER. NO PHOTOGRAPHS ARE AVAILABLE FOR REVIEW. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE MALFUNCTION.
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 THE AQUAA REVERSE OSMOSIS (RO) SYSTEM ALARMED WITH ERROR CODE "F¿01¿04¿01 FAILURE: HTU BK I/O BUS FAILURE." THE BIOMED STATED UPON INITIAL FOLLOW-UP THAT THE HT IS BLOWING A 2-AMP BUS FUSE AT F5. THE PART WAS THERMALLY DAMAGED AND UPON FURTHER FOLLOW-UP IT WAS REPORTED THAT SPARKING OCCURRED WHEN ATTEMPTING TO REPLACE THE PART. THE BIOMED TRACED THE CAUSE TO THE PT-5 SENSOR. THE FUSE AND PT-5 SENSOR WERE REPLACED TO RESOLVE THE REPORTED ISSUES. THE SYSTEM WAS RETURNED TO FULL SERVICE FOLLOWING REPAIR. NO PARTS WERE RETURNED TO THE MANUFACTURER. NO PHOTOGRAPHS ARE AVAILABLE FOR REVIEW. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE MALFUNCTION.
Additional Manufacturer Narrative
PLANT INVESTIGATION: NO SAMPLE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. NO PHOTOGRAPHS OR MACHINE FILES WERE PROVIDED FOR REVIEW. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED. THE DEVICE WAS FOUND TO BE CONFORMING TO SPECIFICATION AND RELEASED WITHOUT ANY DISCREPANCIES. THE MANUFACTURER WAS ABLE TO CONFIRM THE REPORTED ISSUE USING THE INFORMATION PROVIDED BY THE CUSTOMER. A SHORTAGE OF THE P-T5 SENSOR AT THE AQUAHT WAS IDENTIFIED AS THE FAILURE CAUSE. THIS IDENTIFIED PRODUCT PROBLEM CAN BE ASSIGNED TO A SUPPLIED MATERIAL.