2008T HEMODIALYSIS SYSTEM W/BIBAG
Received Jul 10, 2026 · Event occurred Jun 26, 2026
Report 0008030665-2026-01762 · MDR key 25780476
Device
Generic name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Manufacturer
Erika De Reynosa, S.a. De C.v.Catalog number
190766
Product problems
- Thermal Decomposition of Device
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
PLANT INVESTIGATION: THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
Description of Event or Problem
A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS CALLED ONSITE TO REPAIR A 2008T HEMODIALYSIS (HD) MACHINE WITH A BURNING SMELL. THE CAUSE WAS FLUID DRIPPED INTO THE CARD CAGE AND DAMAGE THE BRIDGE RECTIFIER, CAUSING THE POWER SUPPLY TO BURN THE WIRE AND BRIDGE RECTIFIER. AFTER REPLACING WITH THE NEW POWER SUPPLY, THE HD MACHINE POWER ON AND OFF WITHOUT ANY ISSUES. THE HD MACHINE COMPLETED REPAIR AS OF 06/26/2026. AFTER REPLACING WITH THE NEW POWER SUPPLY, THE HD MACHINE WAS PLACED INTO DIALYSIS TREATMENT FUNCTIONAL CHECK/ TEST WHICH PASSES 6X AND COMPLETED REPAIR WITH A VINEGAR/ HEAT AS OF 06/26/2026. THERE WAS NO PATIENT INVOLVEMENT OR INJURY NOTED AT INTAKE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT RECEIVED TO DATE.