AQUAA 1800H
Received Oct 18, 2024 · Event occurred Oct 7, 2024
Report 3010850471-2024-00089 · MDR key 20481754
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: THE CURRENT DEVICE STATUS IS UNKNOWN. NO PARTS WERE AVAILABLE FOR PHYSICAL EVALUATION. NO MACHINE FILES WERE PROVIDED FOR REVIEW. A REVIEW OF DEVICE HISTORY RECORD (DHR) WAS PERFORMED. THE DEVICE WAS BEEN FOUND TO BE CONFORMING TO THE SPECIFICATIONS AND WAS BEEN RELEASED WITHOUT ANY DISCREPANCIES. THE MANUFACTURER CONFIRMED THE REPORTED EVENT AFTER REVIEWING THE PROVIDED INTAKE INFORMATION, HOWEVER THE CAUSE CANNOT BE DETERMINED. NO FURTHER RECOMMENDATION CAN BE MADE.
Description of Event or Problem
A BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS THAT A BURNING SMELL WAS OBSERVED FROM THE AQUAA REVERSE OSMOSIS (RO) SYSTEM IN SUPPLY MODE. THE BIOMED EVALUATED THE SYSTEM AND IDENTIFIED THAT PUMP (P1) AND CONNECTED WIRING WAS BURNED. THE PART NUMBER FOR THE GRUNDFOS PUMP CRN 3-11 WAS PROVIDED UPON REQUEST SO A REPLACEMENT COULD BE ORDERED AND INSTALLED TO RESOLVE THIS ISSUE. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER A RESPONSE WAS NOT RECEIVED. NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION WAS REPORTED. NO PARTS WERE 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
A BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS THAT A BURNING SMELL WAS OBSERVED FROM THE AQUAA REVERSE OSMOSIS (RO) SYSTEM IN SUPPLY MODE. THE BIOMED EVALUATED THE SYSTEM AND IDENTIFIED THAT PUMP (P1) AND CONNECTED WIRING WAS BURNED. THE PART NUMBER FOR THE GRUNDFOS PUMP CRN 3-11 WAS PROVIDED UPON REQUEST SO A REPLACEMENT COULD BE ORDERED AND INSTALLED TO RESOLVE THIS ISSUE. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER A RESPONSE WAS NOT RECEIVED. NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION WAS REPORTED. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.