MalfunctionFIL
FRESENIUS DIALYSIS DELIVERY SYSTEM
Received Jul 1, 2002 · Event occurred May 29, 2002
Report 2937457-2002-00031 · MDR key 403408
Device
Generic name
Hemodialysis Machine
Manufacturer
Fresenius Medical Care-north AmericaModel number
2008KCatalog number
NA
Lot number
NA
Product problems
- Inadequate Ultra Filtration
- Insufficient Flow or Under Infusion
- Other (for use when an appropriate device code cannot be identified)
Patient
UNKNOWN
- Low Blood Pressure/ Hypotension
- Pain
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Description of Event or Problem
THE FACILITY REPORTED THAT THERE WAS EXCESSIVE ULTRAFILTRATION (UF) RATE DURING THE FIRST TWO HOURS OF A HEMODIALYSIS TREATMENT. UF GOAL WAS 3,300 FOR 4 HRS. USING UF PROFILE #2. STARTING UF RATE WAS 2210 WHICH WAS HIGHER THAN EXPECTED. THE PATIENT WAS HYPOTENSIVE AND COMPLAINING OF LEG PAIN. TREATMENT WAS COMPLETED WITH THE UF SET AT 30 ML/HR. THERE WAS NO SERIOUS INJURY OR ILLNESS.
Remedial action
- Other