MalfunctionFIL
FRESENIUS DIALYSIS DELIVERY SYSTEM
Received Aug 10, 2005 · Event occurred Jun 8, 2005
Report 2937457-2005-00013 · MDR key 627743
Device
Generic name
Hemodialysis Machine
Manufacturer
Fresenius Medical Care North AmericaModel number
2008KCatalog number
NA
Lot number
NA
Product problems
- Output, high
Patient
53 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
USER FACILITY RECEIVED A REPORT REGARDING ULTRAFILTRATION IN EXCESS OF 1.1 KG. OF THE AIMED FLUID LOSS DURING A HEMODIALYSIS TREATMENT. NO INTERVENTION REQUIRED.