MalfunctionFIL
FRESENIUS DIALYSIS DELIVERY SYSTEM
Received Mar 28, 2003 · Event occurred Feb 26, 2003
Report 2937457-2003-00009 · MDR key 451474
Device
Generic name
Hemodialysis
Manufacturer
Fresenius Medical Care-north AmericaModel number
2008KCatalog number
NA
Lot number
NA
Product problems
- Inadequate Ultra Filtration
- Other (for use when an appropriate device code cannot be identified)
Patient
UNKNOWN
- Cramp(s)
- Treatment with medication(s)
Narrative
Description of Event or Problem
FACILITY REPORTED THAT THE UF (ULTRAFILTRATION) RATE WAS HIGHER THAN EXPECTED DURING A HEMODIALYSIS TREATMENT. AFTER THE UF GOAL WAS CHANGED FROM 3900 TO 4000, THE UF RATE CHANGED TO 1960. EXPECTED UF RATE WOULD HAVE BEEN AROUND 1300. THE PT COMPLAINT OF CRAMPING AND WAS GIVEN SALINE. THERE WAS NO SERIOUS INJURY/ILLNESS.
Remedial action
- Other