GRANUFLO DISSOLUTION TANK
Received Jun 8, 2026 · Event occurred May 26, 2026
Report 0008030665-2026-01130 · MDR key 25427463
Device
Generic name
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
Manufacturer
Erika De Reynosa, S.a. De C.v.Catalog number
RTLG047-80101
Product problems
- Thermal Decomposition of Device
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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
THE USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE GRANUFLO DISSOLUTION TANK SKIPS THE FILL AND TRANSFER CYCLES. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THE BIOMED EVALUATED THE MIXER. THERMAL DECOMPOSITION WAS IDENTIFIED ON THE MOTOR. THE MOTOR WAS REPLACED TO RESOLVE THE REPORTED ISSUE. THE MACHINE WAS RETURNED TO SERVICE FOLLOWING REPAIR. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. NO PHOTOGRAPHS WERE AVAILABLE FOR REVIEW. THERE WAS NO HARM TO ANY INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5 (EVENT DESCRIPTION) THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
Description of Event or Problem
THE USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE GRANUFLO DISSOLUTION TANK SKIPS THE FILL AND TRANSFER CYCLES. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THE BIOMED STATED THAT PLASTIC INSIDE OF THE MOTOR HAD MELTED. NO SMOKE, SPARK, FLAME, OR ARCING WAS OBSERVED. IT WAS DETERMINED THAT THE THERMAL DECOMPOSITION RESULTED FROM THE WATER SIDE OF THE ENGINE BEING EMPTY. IT COULD NOT BE CONFIRMED WHETHER THE PART WAS ORIGINAL GIVEN THE AGE OF THE MACHINE. THE MOTOR WAS REPLACED TO RESOLVE THE REPORTED ISSUE. THE MACHINE SENSORS WERE TESTED DURING EVALUATION AND DETERMINED TO BE IN WORKING CONDITION AND DID NOT REQUIRE REPLACEMENT. THE MACHINE IS IN FULL SERVICE AND HAS COMPLETED MULTIPLE BATCHES SINCE REPAIR WITHOUT ISSUE. THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. NO PHOTOGRAPHS WERE AVAILABLE FOR REVIEW. THERE WAS NO HARM TO ANY INDIVIDUALS AS A RESULT OF THIS MALFUNCTION.