MalfunctionFIL
FRESENIUS DIALYSIS DELIVERY SYSTEM
Received Jul 1, 2002 · Event occurred May 28, 2002
Report 2937457-2002-00030 · MDR key 403405
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
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
FRESENIUS MEDICAL CARE CANADA, INC. REPORTED THAT THERE WAS EXCESSIVE ULTRAFILTRATION (UF) RATE DURING THE FIRST TWO HOURS OF A HEMODIALYSIS TREATMENT. UF GOAL WAS 2,400 FOR 4 HRS. USING UF PROFILE #2. STARTING UF RATE WAS 1500 WHICH WAS HIGHER THAN EXPECTED. UF GOAL WAS REACHED WITHIN 2 HRS. THE PATIENT WAS WEIGHED AND WAS AT DRY WEIGHT. TREATMENT WAS COMPLETED WTIH THE UF OFF. THERE WAS NO SERIOUS INJURY OR ILLNESS.
Remedial action
- Other