2008T HEMODIALYSIS SYS., WITH CDX
Received Jul 16, 2026 · Event occurred Jul 14, 2026
Report 0008030665-2026-01875 · MDR key 25840598
Device
Generic name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Manufacturer
Erika De Reynosa, S.a. De C.v.Catalog number
190713
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 HAD A MELTED FLOAT SWITCH ON THE HYDROCHAMBER. THEY BMT HAD RECENTLY REPLACED THE HYDROCHAMBER AND WHEN THE DEVICE WAS POWERED ON, WATER WAS SPRAYING FROM THE VENT TUBE. THE BMT REMOVED THE FLOAT SWITCH AND FOUND IT WAS MELTED PREVENTING THE FLOAT FROM MOVING FREELY. UPON FOLLOW UP, THE BMT SAID THAT THE ISSUE WAS NOTICED DURING MACHINE REPAIR. 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 HYDROCAHMBER WAS BRAND NEW AND THIS AS AN OUT-OF-BOX FAILURE. THE BMT REPORTED THAT THERE WAS NO BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING OBSERVED. THE BMT REPORTED THAT THE MACHINE HAS NOT HAD ANY PAST PROBLEMS WITH FAILING THE ELECTRICAL LEAKAGE TEST AND THAT THERE WAS NO DAMAGE OBSERVED ON ANY OTHER COMPONENTS. THE MACHINE HAS APPROXIMATELY 34,000 HOURS AND IS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THE BMT REPLACED THE HYDROCAHMBER, WHICH RESOLVED THE ISSUE. THE BMT REPORTED THAT THE MACHINE HAS BEEN RETURNED TO SERVICE WITHOUT ISSUE. THE HYDROCAHMBER IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.