MalfunctionFIL
FRESENIUS DIALYSIS DELIVERY SYSTEM
Received Aug 1, 2002 · Event occurred Jul 3, 2002
Report 2937457-2002-00037 · MDR key 409765
Device
Generic name
Hemodialysis Machine
Manufacturer
Fresenius Medical Care North AmericaModel number
2008KCatalog number
NA
Lot number
NA
Product problems
- High flux rate
- Inadequate Ultra Filtration
- Other (for use when an appropriate device code cannot be identified)
Patient
UNKNOWN
- No Consequences Or Impact To Patient
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
A DIALYSIS FACILITY REPORTED THAT ULTRAFILTRATION (UF) RATE WAS HIGHER THAN EXPECTED DURING A HEMODIALYSIS TREATMENT. UF GOAL WAS REACHED IN ABOUT 2.5 HRS INSTEAD OF 3.5 HRS. THERE WAS NO REPORTED SERIOUS INJURY/ILLNESS. AVAILABLE INFORMATION IS LIMITED.
Remedial action
- Other