AQUABPLUS, HF 1000
Received Oct 11, 2023 · Event occurred Dec 28, 2022
Report 3010850471-2023-00074 · MDR key 17913080
Device
Product problems
- Thermal Decomposition of Device
- Thermal Decomposition of Device
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
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.
Description of Event or Problem
IT WAS REPORTED TO FRESENIUS THAT THERMAL DAMAGE WAS DISCOVERED IN THE PRINCIPAL SWITCH OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THIS INDICATION OF THERMAL DAMAGE REPRESENTS A FAILURE IN THE ELECTRICAL SYSTEM. THE PRINCIPAL SWITCH WAS REPLACED TO RESOLVE THE REPORTED ISSUE. THERE WAS NO REPORTED PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANYONE AS A RESULT OF THE IDENTIFIED THERMAL DAMAGE. IT HAS NOT BEEN INDICATED THAT A SAMPLE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.
Description of Event or Problem
IT WAS REPORTED TO FRESENIUS THAT THERMAL DAMAGE WAS DISCOVERED IN THE PRINCIPAL SWITCH OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THIS INDICATION OF THERMAL DAMAGE REPRESENTS A FAILURE IN THE ELECTRICAL SYSTEM. THE PRINCIPAL SWITCH WAS REPLACED TO RESOLVE THE REPORTED ISSUE. THERE WAS NO REPORTED PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANYONE AS A RESULT OF THE IDENTIFIED THERMAL DAMAGE. IT HAS NOT BEEN INDICATED THAT A SAMPLE IS 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.