2008T HD SYS. W/O CDX W/BIBAG BLUE STAR
Received Jul 20, 2026 · Event occurred Jul 10, 2026
Report 0008030665-2026-01926 · MDR key 25876231
Device
Generic name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Manufacturer
Erika De Reynosa, S.a. De C.v.Catalog number
191130
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
A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A 2008T HEMODIALYSIS (HD) MACHINE EMITTED A BURNING SMELL DURING CLEANING MODE. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS CALLED ONSITE AND ORDERED A UI/ MICS BOARD FOR THE CUSTOMER. UPON FOLLOW UP, THE BMT SAID THAT THE USER INTERFACE (UI) BOARD AND ITS CABLE HAD A BURNING SMELL AND THE UI/ MICS BOARD WAS BURNT. A PATIENT WAS NOT CONNECTED TO THE MACHINE AT THE TIME OF THE INCIDENT AND THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. THE MACHINE REMAINS OUT OF SERVICE AS THEY ARE WAITING FOR A PART TO ARRIVE. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONTACT THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.