MalfunctionFIL
FRESENIUS DIALYSIS DELIVERY SYSTEM
Received Mar 12, 2002 · Event occurred Feb 13, 2002
Report 2937457-2002-00019 · MDR key 383281
Device
Generic name
Hemodialysis Machine
Manufacturer
Fresenius Medical Care-north AmericaModel number
2008KCatalog number
NA
Lot number
NA
Product problems
- Increase in Pressure
- Replace
- Insufficient Flow or Under Infusion
Patient
40 YR
- Other (for use when an appropriate patient code cannot be identified)
- Therapy/non-surgical treatment, aborted/stopped
- Weight Changes
Narrative
Description of Event or Problem
A DIALYSIS FACILITY REPORTED THAT A PATIENT REMOVED MORE FLUID THAN DESIRED DURING A HEMODIALYSIS TREATMENT. INFORMATION AVAILABLE AT THIS TIME IS VERY LIMITED. THE PATIENT WAS WEIGHED 1.5 HRS. INTO THE TREATMENT AND HAD LOST 2.9 KG. THE MACHINE INDICATED THAT 960 ML. WAS REMOVED. TREATMENT WAS COMPLETED ON ANOTHER MACHINE WITH NO PROBLEMS.