AQUABPLUS, B2, HF 1500 KIT
Received Dec 17, 2024 · Event occurred Nov 24, 2024
Report 3010850471-2024-00108 · MDR key 20952480
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. HOWEVER, THE REPORTED ISSUE WAS CONFIRMED BY THE MANUFACTURER BY MEANS OF THE INFORMATION PROVIDED BY THE CUSTOMER. THE MANUFACTURER DETERMINED THE CAUSE OF THE REPORTED ISSUE TO BE AN INADEQUATE DESIGN OF THE CABLE LUGS, WHICH RESULTED IN BAD ELECTRICAL CONTACTING AT THE CABLE/CABLE LUG ATTACHED TO THE MOTOR PROTECTION SWITCH. THIS FAILURE IS A KNOWN ISSUE. CORRECTIVE ACTIONS HAVE BEEN DEFINED. A DESIGN CHANGE FOR A DIFFERENT MOTOR PROTECTION SWITCH TYPE AND ELECTRICAL CONNECTION IS GOING TO BE IMPLEMENTED. THE NEW DESIGN IS CURRENTLY NOT AVAILABLE FOR THE US MARKET. ACCORDING TO THE PROVIDED INFORMATION, THE CONCERNED CABLE AND THE MOTOR PROTECTION SWITCH WERE REPLACED TO RESOLVE THE ISSUE. A DEVICE HISTORY RECORD (DHR) REVIEW INDICATED THAT NO ISSUES WITH THE WIRING/CABLE LUGS AND/OR THE MOTOR PROTECTION SWITCH WERE ENCOUNTERED DURING TESTING.
Description of Event or Problem
THE BIOMEDICAL TECHNICIAN (BIOMED) FOR A USER FACILITY REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE CABLES CONNECTING THE MOTOR PROTECTION SWITCH (MPS) TO THE CONTACTOR WERE BURNED AND MELTED TO THE TERMINAL CONNECTOR. AN ERROR REGARDING THE DEFECTIVE P1S WAS RECEIVED BUT THE EXACT CODE WAS NOT PROVIDED. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THERE WAS NO OBSERVED SMOKE, SPARK, FLAME, OR ARCING. THE BIOMED STATED THE CABLE AND SWITCH WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS RETURNED TO SERVICE FOLLOWING REPAIR. THE PARTS WERE DISCARDED AND ARE NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS THAT RESULTED FROM THE REPORTED ISSUE.
Description of Event or Problem
THE BIOMEDICAL TECHNICIAN (BIOMED) FOR A USER FACILITY REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE CABLES CONNECTING THE MOTOR PROTECTION SWITCH (MPS) TO THE CONTACTOR WERE BURNED AND MELTED TO THE TERMINAL CONNECTOR. AN ERROR REGARDING THE DEFECTIVE P1S WAS RECEIVED BUT THE EXACT CODE WAS NOT PROVIDED. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THERE WAS NO OBSERVED SMOKE, SPARK, FLAME, OR ARCING. THE BIOMED STATED THE CABLE AND SWITCH WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS RETURNED TO SERVICE FOLLOWING REPAIR. THE PARTS WERE DISCARDED AND ARE NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS THAT RESULTED FROM THE REPORTED ISSUE.
Additional Manufacturer Narrative
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.