AQUABPLUS, HF 3000
Report
- Report Number
- 3010850471-2023-00081
- Event Type
- Malfunction
- Date Received
- October 25, 2023
- Date of Event
- July 15, 2022
- Report Date
- July 31, 2024
- Manufacturer
- VIVONIC GMBH
- Product Code
- FIP
- PMA / PMN Number
- K143617
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EC
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
PLANT INVESTIGATION: PHYSICAL EVALUATION OF A SAMPLE WAS NOT REQUIRED FOR THIS CASE. THE REPORTED ISSUE WAS CONFIRMED USING THE PROVIDED INFORMATION. THE CAUSE OF THE REPORTED FAILURE WAS DETERMINED TO BE A BAD ELECTRICAL CONTACT OF THE WIRING AT THE MOTOR PROTECTION SWITCH. THE DAMAGE RESULTED FROM EITHER (1) THE ELECTRICAL CONTACT AT THE MOTOR PROTECTION SWITCH PUMP P1(S) RUNNING WITH ONLY TWO LINE CONDUCTORS OR (2) THE INNER BIMETAL CONTACT OF THE MOTOR PROTECTION TRIPPING FROM INCREASED TEMPERATURE CAUSED BY THE TRANSITION RESISTANCE OF THE ELECTRICAL CONTACT. BOTH ISSUES RESULT IN HIGHER CURRENTS AND HIGHER THERMAL ENERGY, AND ULTIMATELY THERMAL DECOMPOSITION. THIS FAILURE IS A KNOWN ISSUE. A ROOT CAUSE ANALYSIS IS IN PROGRESS AND CORRECTIVE/PREVENTIVE ACTIONS WILL BECOME AVAILABLE WITH AN IMPROVED DESIGN FOR THE ELECTRICAL MONITOR, WHICH INCLUDES THE WIRING AT THE MAIN SWITCH (THE MOTOR PROTECTION SWITCH IN THE CURRENT DESIGN). THE IMPROVED DESIGN IS CURRENTLY NOT AVAILABLE FOR THE AFFECTED MARKET SEGMENT, BUT THE RELEASE IS PLANNED BY COMPLETION OF THE DESIGN CHANGE. ACCORDING TO THE PROVIDED INFORMATION, THE MOTOR PROTECTION SWITCH, CONTACTOR AND THE WIRING WERE REPLACED TO SOLVE THE ISSUE. THE CURRENT STATUS OF THE MACHINE IS UNKNOWN. IT IS RECOMMENDED, IF NOT ALREADY DONE, TO REPLACE THE WIRING AND THE MOTOR PROTECTION SWITCH IN STAGE 1 AND STAGE 2 WITH THE AVAILABLE DESIGN. ONLY INSTALLATION OF MANUFACTURER SPARE PARTS IS ADVISED.
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
IT WAS REPORTED TO FRESENIUS THAT THERMAL DAMAGE WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE DAMAGE WAS RELATED TO THE IGNITION SWITCH GROUP, ELECTRICAL CONTACTOR OF THE PRESSURE PUMP, AND THE ELECTRICAL WIRING OF THE CONNECTION BETWEEN THE MAIN IGNITION SWITCH AND THE ELECTRICAL CONTACTOR THAT FEEDS THE PRESSURE PUMP OF THE RO SYSTEM. FAILURE DUE TO THE EFFECT OF HEAT DAMAGE WAS EVIDENT FROM A VISUAL INSPECTION. THERE WERE CABLES WITH MELTED THERMAL INSULATION AS WELL AS SULFATED TERMINALS. THE REPORTED ISSUE WAS DISCOVERED DURING PREVENTATIVE MAINTENANCE (PM). THERE WAS NO PATIENT INVOLVEMENT NOR REPORTED PERSONAL HARM TO ANYONE AS A RESULT OF ENCOUNTERING THE REPORTED THERMAL DAMAGE. THE CABLE GAUGE WAS REPLACED IN ORDER TO SUPPORT A GREATER LOAD OF CURRENT INTENSITY, THE SULFATED TERMINALS AND FAULTY CONTACTORS WERE ALSO REPLACED TO RESOLVE THE REPORTED ISSUE. IT WAS REPORTED THAT THE MACHINE HAS APPROXIMATELY 11,412 HOURS. IT WAS NOT REPORTED THAT ANY SAMPLES ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE MACHINE DATA IS AVAILABLE FOR REVIEW BY THE MANUFACTURER.
IT WAS REPORTED TO FRESENIUS THAT THERMAL DAMAGE WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE DAMAGE WAS RELATED TO THE IGNITION SWITCH GROUP, ELECTRICAL CONTACTOR OF THE PRESSURE PUMP, AND THE ELECTRICAL WIRING OF THE CONNECTION BETWEEN THE MAIN IGNITION SWITCH AND THE ELECTRICAL CONTACTOR THAT FEEDS THE PRESSURE PUMP OF THE RO SYSTEM. FAILURE DUE TO THE EFFECT OF HEAT DAMAGE WAS EVIDENT FROM A VISUAL INSPECTION. THERE WERE CABLES WITH MELTED THERMAL INSULATION AS WELL AS SULFATED TERMINALS. THE REPORTED ISSUE WAS DISCOVERED DURING PREVENTATIVE MAINTENANCE (PM). THERE WAS NO PATIENT INVOLVEMENT NOR REPORTED PERSONAL HARM TO ANYONE AS A RESULT OF ENCOUNTERING THE REPORTED THERMAL DAMAGE. THE CABLE GAUGE WAS REPLACED IN ORDER TO SUPPORT A GREATER LOAD OF CURRENT INTENSITY, THE SULFATED TERMINALS AND FAULTY CONTACTORS WERE ALSO REPLACED TO RESOLVE THE REPORTED ISSUE. IT WAS REPORTED THAT THE MACHINE HAS APPROXIMATELY 11,412 HOURS. IT WAS NOT REPORTED THAT ANY SAMPLES ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE MACHINE DATA IS AVAILABLE FOR REVIEW BY THE MANUFACTURER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1733654 | AQUABPLUS, HF 3000 | SUBSYSTEM, WATER PURIFICATION | FIP | VIVONIC GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |