AQUABPLUS 2500 B2 2000
Received Oct 21, 2025 · Event occurred Oct 10, 2025
Report 3010850471-2025-00015 · MDR key 23349601
Device
Product problems
- Sparking
- Sparking
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- 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 THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN THE AQUAB PLUS REVERSE OSMOSIS (RO) SYSTEM AT THE BACK OF THE STAGE 1 MOTOR PROTECTION SWITCH (MPS). A SPARK WAS ALSO NOTED WHEN STARTING P1 DURING THE INITIAL TEST. REPLACING THE MPS RESOLVED THIS ISSUE. THE RO SYSTEM WAS RETURNED TO FULL SERVICE FOLLOWING REPAIR. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THIS MALFUNCTION. NO PARTS ARE EXPECTED 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
THE BIOMEDICAL TECHNICIAN (BIOMED) FOR A USER FACILITY REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN THE AQUAB PLUS REVERSE OSMOSIS (RO) SYSTEM AT THE BACK OF THE STAGE 1 MOTOR PROTECTION SWITCH (MPS). A SPARK WAS ALSO NOTED WHEN STARTING P1 DURING THE INITIAL TEST. REPLACING THE MPS RESOLVED THIS ISSUE. THE RO SYSTEM WAS RETURNED TO FULL SERVICE FOLLOWING REPAIR. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THIS MALFUNCTION. NO PARTS ARE EXPECTED TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.
Additional Manufacturer Narrative
PLANT INVESTIGATION: NO SAMPLE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER, THE REPORTED EVENT WAS CONFIRMED BY MEANS OF THE PROVIDED COMPLAINT INTAKE INFORMATION. ACCORDING TO THE AVAILABLE INFORMATION, THERMAL DAMAGE WAS IDENTIFIED ON THE MOTOR PROTECTION SWITCH STAGE 1 AND/OR THE CONNECTED WIRING. A SPARK WAS NOTICED WHEN PUMP P1 STARTED RUNNING. THE MOTOR PROTECTION SWITCH WAS REPLACED TO SOLVE THE ISSUE. THE DHR RELATED DOCUMENTATION HAS BEEN REVIEWED. NO SUCH ISSUE OCCURRED WITHIN THE FINAL TESTING PROCEDURE. THE DEVICE HAS BEEN FOUND TO BE CONFORMING TO THE SPECIFICATIONS AND HAS BEEN RELEASED WITHOUT ANY DISCREPANCIES.