AQUABPLUS, HF 3000
Received Sep 22, 2023 · Event occurred Dec 23, 2019
Report 3010850471-2023-00065 · MDR key 17801151
Device
Product problems
- Thermal Decomposition of Device
- Melted
- Thermal Decomposition of Device
- Melted
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE MANUFACTURER DETERMINED THE CAUSE OF THE REPORTED FAILURE TO BE A BAD ELECTRICAL CONTACT OF THE WIRING AT THE MOTOR PROTECTION SWITCH. THE BAD CONTACT AT THE MOTOR PROTECTION SWITCH EITHER (1) RUNS THE PUMP P1 WITH TWO LINE CONDUCTORS RESULTING IN HIGHER CURRENT AND THERMAL ENERGY OR (2) THE INNER BIMETAL CONTACT OF THE MOTOR PROTECTION TRIPS DUE TO INCREASED TEMPERATURE CAUSED BY THE TRANSITION RESISTANCE OF THE CONTACT. IN BOTH CASES THE MOTOR PROTECTION SWITCH TRIPS AND THE DEVICE IS POWERED OFF. THE RESULT IS THERMAL DAMAGE AT THE MOTOR PROTECTION SWITCH FROM INCREASED HEAT RADIATION. THIS FAILURE IS A KNOWN ISSUE. A ROOT CAUSE ANALYSIS IS IN PROGRESS. THE DESIGN OF THE BLADE RECEPTACLE AT THE MOTOR PROTECTION SWITCH WAS DETERMINED TO BE INADEQUATE. CORRECTIVE/PREVENTIVE ACTIONS WILL BECOME AVAILABLE WITH AN IMPROVED DESIGN FOR THE ELECTRICAL MONITOR, WHICH INCLUDES THE WIRING AT THE MAIN SWITCH. THE DESIGN CHANGE IS APPROVED BUT CURRENTLY NOT IMPLEMENTED. THE IMPROVED DESIGN IS CURRENTLY NOT AVAILABLE FOR THE AFFECTED MARKET SEGMENT, BUT THE RELEASE IS PLANNED BY COMPLETION OF THE DESIGN CHANGE. THE CURRENT STATUS OF THE MACHINE IS UNKNOWN. BASED ON THE PICTURES AVAILABLE, LOCAL PARTS WERE USED TO REPAIR THE MACHINE/SOLVE THE PROBLEM. IT IS RECOMMENDED TO REPLACE, IF NOT ALREADY DONE, THE WIRING AND THE MOTOR PROTECTION SWITCH IN STAGE 1 AND STAGE 2 WITH THE AVAILABLE DESIGN.
Description of Event or Problem
IT WAS REPORTED TO FRESENIUS THAT ELECTRICAL CABLES AND THE POWER SWITCH OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM HAD SUSTAINED HEAT DAMAGE AND WERE MELTED. THE REPORTED ISSUE WAS DISCOVERED DURING MACHINE REPAIR. AN EVALUATION INITIALLY TOOK PLACE TO INCREASE THE TEMPERATURE OF THE RO SYSTEM. INITIALLY THE CABLES AND PROTECTION SWITCH WERE REPLACED TO RESOLVE THE REPORTED ISSUE. LATER AN ELECTRICAL PANEL WAS ALSO INSTALLED. THERE WAS NO PATIENT INVOLVEMENT NOR REPORTED HARM AS A RESULT OF THIS ISSUE. NO SAMPLES ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.
Description of Event or Problem
IT WAS REPORTED TO FRESENIUS THAT ELECTRICAL CABLES AND THE POWER SWITCH OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM HAD SUSTAINED HEAT DAMAGE AND WERE MELTED. THE REPORTED ISSUE WAS DISCOVERED DURING MACHINE REPAIR. AN EVALUATION INITIALLY TOOK PLACE TO INCREASE THE TEMPERATURE OF THE RO SYSTEM. INITIALLY THE CABLES AND PROTECTION SWITCH WERE REPLACED TO RESOLVE THE REPORTED ISSUE. LATER AN ELECTRICAL PANEL WAS ALSO INSTALLED. THERE WAS NO PATIENT INVOLVEMENT NOR REPORTED HARM AS A RESULT OF THIS ISSUE. NO SAMPLES ARE AVAILABLE 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
IT WAS REPORTED TO FRESENIUS THAT ELECTRICAL CABLES AND THE POWER SWITCH OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM HAD SUSTAINED HEAT DAMAGE AND WERE MELTED. THE REPORTED ISSUE WAS DISCOVERED DURING MACHINE REPAIR. AN EVALUATION INITIALLY TOOK PLACE TO INCREASE THE TEMPERATURE OF THE RO SYSTEM. INITIALLY THE CABLES AND PROTECTION SWITCH WERE REPLACED TO RESOLVE THE REPORTED ISSUE. LATER AN ELECTRICAL PANEL WAS ALSO INSTALLED. THERE WAS NO PATIENT INVOLVEMENT NOR REPORTED HARM AS A RESULT OF THIS ISSUE. NO SAMPLES ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.