AQUABPLUS 2500 B2 2000
Received Feb 17, 2026 · Event occurred Feb 12, 2026
Report 3010850471-2026-00004 · MDR key 24365965
Device
Product problems
- Smoking
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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 AREA TECHNICAL OPERATIONS MANAGER (ATOM) FOR A USER FACILITY REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE WIRES CONNECTED TO THE STAGE 1 MOTOR PROTECTION SWITCH (MPS) OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM BURNED AND PRODUCED SMOKE. THE RO SYSTEM WAS UNDER EVALUATION FOR HAVING NO POWER UPON DISCOVERY OF THE REPORTED ISSUE. THE SMOKE DID NOT TRIGGER FACILITY SMOKE DETECTORS. THE LOCAL FIRE DEPARTMENT WAS NOT DISPATCHED. USE OF A FIRE EXTINGUISHER WAS NOT REQUIRED TO ADDRESS THE SMOKE. THE ATOM RESPONDED TO THE SMOKE BY SHUTTING OFF POWER TO THE BREAKER. THE RO SYSTEM WAS PLACED IN EMERGENCY MODE STAGE 2. THE ATOM STATED THE WIRES ALONG WITH THE MPS WERE REPLACED TO RESOLVE THE REPORTED ISSUE. FRESENIUS ASSISTED THE ATOM WITH WIRING THE MPS. THE RO SYSTEM PASSED THE T1 TEST. THE RO SYSTEM WAS RETURNED TO SERVICE. THERE WAS NO PATIENT INVOLVEMENT REGARDING THIS ISSUE. NO PARTS WERE REPORTED TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.
Description of Event or Problem
THE AREA TECHNICAL OPERATIONS MANAGER (ATOM) FOR A USER FACILITY REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE WIRES CONNECTED TO THE STAGE 1 MOTOR PROTECTION SWITCH (MPS) OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM BURNED AND PRODUCED SMOKE. THE RO SYSTEM WAS UNDER EVALUATION FOR HAVING NO POWER UPON DISCOVERY OF THE REPORTED ISSUE. THE SMOKE DID NOT TRIGGER FACILITY SMOKE DETECTORS. THE LOCAL FIRE DEPARTMENT WAS NOT DISPATCHED. USE OF A FIRE EXTINGUISHER WAS NOT REQUIRED TO ADDRESS THE SMOKE. THE ATOM RESPONDED TO THE SMOKE BY SHUTTING OFF POWER TO THE BREAKER. THE RO SYSTEM WAS PLACED IN EMERGENCY MODE STAGE 2. THE ATOM STATED THE WIRES ALONG WITH THE MPS WERE REPLACED TO RESOLVE THE REPORTED ISSUE. FRESENIUS ASSISTED THE ATOM WITH WIRING THE MPS. THE RO SYSTEM PASSED THE T1 TEST. THE RO SYSTEM WAS RETURNED TO SERVICE. THERE WAS NO PATIENT INVOLVEMENT REGARDING THIS ISSUE. NO PARTS WERE REPORTED TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.
Additional Manufacturer Narrative
PLANT INVESTIGATION: A SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER, THE MANUFACTURER WAS ABLE TO CONFIRM THE REPORTED ISSUE BASED ON THE PROVIDED INFORMATION. A BAD ELECTRICAL CONTACT WAS DETERMINED TO BE THE CAUSE FOR THE REPORTED ISSUE WHICH RESULTED IN THERMAL DECOMPOSITION OF THE MENTIONED WIRING. THIS EVENT REPRESENTS A KNOWN FAILURE. CORRECTIVE ACTIONS HAVE BEEN DEFINED AND IMPLEMENTED. AN IMPROVEMENT WAS MADE TO THE WIRING DESIGN AND RELEASED. ACCORDING TO THE INTAKE INFORMATION, THE WIRING WAS REPLACED TO SOLVE THE REPORTED ISSUE.