DRY ACID 99 GALLON UNIT, ASSY TO SHIP
Received Jun 5, 2026 · Event occurred May 6, 2026
Report 0008030665-2026-01126 · MDR key 25408735
Device
Generic name
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
Manufacturer
Erika De Reynosa, S.a. De C.v.Catalog number
RTL160148
Product problems
- Thermal Decomposition of Device
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A user facility biomedical technician (biomed) reported to Fresenius technical support that a Dry Acid Mixer would not fill in rinse mode. The biomed stated that no water was coming through the jet nozzles or the center (bottom) of the tank. Upon follow-up it was reported that "burnt wires from the pump" were found while troubleshooting the issue. The biomed also said that a faint burning smell was noticed. There were no signs of any smoke, sparks, or flames. The biomed replaced the burnt wires and this resolved the issue. No other parts had to be replaced. Multiple attempts were made to obtain additional information, and thus far no further details have been provided.
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 USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SUPPORT THAT A DRY ACID MIXER WOULD NOT FILL IN RINSE MODE. THE BIOMED STATED THAT NO WATER WAS COMING THROUGH THE JET NOZZLES OR THE CENTER (BOTTOM) OF THE TANK. UPON FOLLOW-UP IT WAS REPORTED THAT "BURNT WIRES FROM THE PUMP" WERE FOUND WHILE TROUBLESHOOTING THE ISSUE. THE BIOMED ALSO SAID THAT A FAINT BURNING SMELL WAS NOTICED. THERE WERE NO SIGNS OF ANY SMOKE, SPARKS, OR FLAMES. THE BIOMED REPLACED THE BURNT WIRES AND THIS RESOLVED THE ISSUE. NO OTHER PARTS HAD TO BE REPLACED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, AND THUS FAR NO FURTHER DETAILS HAVE BEEN PROVIDED.
Additional Manufacturer Narrative
Plant Investigation: No parts were returned to the manufacturer for physical evaluation. Additionally, no on-site evaluation was performed by a Fresenius Field Service Technician (FST). However, the complaint investigation found objective evidence indicating there was a product problem, and thus the complaint was confirmed. A records review was performed on the reported serial number. An investigation of the device manufacturing records was conducted by the manufacturer. There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event. In addition, the Device History Record (DHR) review confirmed the results of the in-progress and final Quality Control (QC) testing met all requirements. Based on the available information, the reported event has been confirmed.