AQUABPLUS, HF 2000
Report
- Report Number
- 3010850471-2023-00084
- Event Type
- Malfunction
- Date Received
- October 25, 2023
- Date of Event
- January 24, 2021
- Report Date
- July 18, 2024
- Manufacturer
- VIVONIC GMBH
- Product Code
- FIP
- PMA / PMN Number
- K133829
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EC
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
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.
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 AFFECTED COMPONENTS WERE ISOLATED TO THE IGNITION SWITCH GROUP, ELECTRICAL CONTACTOR OF THE PRESSURE PUMP, AND ELECTRICAL WIRING OF THE CONNECTION BETWEEN THE MAIN IGNITION SWITCH AND THE ELECTRICAL CONTACTOR THAT FEEDS THE PRESSURE PUMP OF THE AQUABPLUS EQUIPMENT. THERE WERE VISUAL INDICATIONS OF OVERHEATING ON THE CABLES. THE MACHINE HAS APPROXIMATELY 4,798 OPERATING HOURS. IT WAS DETERMINED THAT THE WIRES OVERHEATED DUE TO AN OVERCURRENT. THE WIRES WERE REPLACED WITH 12 AWG WIRES ON ALL 3 PHASES ALONG WITH SULFATED TERMINALS AND FAULTY CONTACTORS. THE CABLE GAUGE WAS ALSO REPLACED TO ALLOW FOR A GREATER LOAD OF CURRENT INTENSITY. IT WAS NOT REPORTED WHETHER A SAMPLE WAS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO PATIENT INVOLVEMENT NOR REPORTED PERSONAL HARM TO ANY INDIVIDUAL AS A RESULT OF ENCOUNTERING THE THERMAL DAMAGE.
IT WAS REPORTED TO FRESENIUS THAT THERMAL DAMAGE WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE AFFECTED COMPONENTS WERE ISOLATED TO THE IGNITION SWITCH GROUP, ELECTRICAL CONTACTOR OF THE PRESSURE PUMP, AND ELECTRICAL WIRING OF THE CONNECTION BETWEEN THE MAIN IGNITION SWITCH AND THE ELECTRICAL CONTACTOR THAT FEEDS THE PRESSURE PUMP OF THE AQUABPLUS EQUIPMENT. THERE WERE VISUAL INDICATIONS OF OVERHEATING ON THE CABLES. THE MACHINE HAS APPROXIMATELY 4,798 OPERATING HOURS. IT WAS DETERMINED THAT THE WIRES OVERHEATED DUE TO AN OVERCURRENT. THE WIRES WERE REPLACED WITH 12 AWG WIRES ON ALL 3 PHASES ALONG WITH SULFATED TERMINALS AND FAULTY CONTACTORS. THE CABLE GAUGE WAS ALSO REPLACED TO ALLOW FOR A GREATER LOAD OF CURRENT INTENSITY. IT WAS NOT REPORTED WHETHER A SAMPLE WAS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO PATIENT INVOLVEMENT NOR REPORTED PERSONAL HARM TO ANY INDIVIDUAL AS A RESULT OF ENCOUNTERING THE THERMAL DAMAGE.
IT WAS REPORTED TO FRESENIUS THAT THERMAL DAMAGE WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE AFFECTED COMPONENTS WERE ISOLATED TO THE IGNITION SWITCH GROUP, ELECTRICAL CONTACTOR OF THE PRESSURE PUMP, AND ELECTRICAL WIRING OF THE CONNECTION BETWEEN THE MAIN IGNITION SWITCH AND THE ELECTRICAL CONTACTOR THAT FEEDS THE PRESSURE PUMP OF THE AQUABPLUS EQUIPMENT. THERE WERE VISUAL INDICATIONS OF OVERHEATING ON THE CABLES. THE MACHINE HAS APPROXIMATELY 4,798 OPERATING HOURS. IT WAS DETERMINED THAT THE WIRES OVERHEATED DUE TO AN OVERCURRENT. THE WIRES WERE REPLACED WITH 12 AWG WIRES ON ALL 3 PHASES ALONG WITH SULFATED TERMINALS AND FAULTY CONTACTORS. THE CABLE GAUGE WAS ALSO REPLACED TO ALLOW FOR A GREATER LOAD OF CURRENT INTENSITY. IT WAS NOT REPORTED WHETHER A SAMPLE WAS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO PATIENT INVOLVEMENT NOR REPORTED PERSONAL HARM TO ANY INDIVIDUAL AS A RESULT OF ENCOUNTERING THE THERMAL DAMAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1733664 | AQUABPLUS, HF 2000 | SUBSYSTEM, WATER PURIFICATION | FIP | VIVONIC GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |