MalfunctionFIL
FRESENIUS DIALYSIS DELIVERY SYSTEM
Received Nov 1, 2002 · Event occurred Oct 2, 2002
Report 2937457-2002-00041 · MDR key 426339
Device
Generic name
Hemodialysis Machine
Manufacturer
Fresenius Medical Care-north AmericaModel number
2008KCatalog number
NA
Lot number
NA
Product problems
- Output, low
- Inadequate Ultra Filtration
- Unknown (for use when the device problem is not known)
Patient
79 YR
- Cramp(s)
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
A DIALYSIS FACILITY REPORTED THAT THERE WAS EXCESSIVE FLUID REMOVED FROM A PT DURING A HEMODIALYSIS TREATMENT. THE PT C/O CRAMPS 15MIN. BEFORE THE END OF TREATMENT AND WAS GIVEN 300CC OF SALINE. BASED ON THE PRE AND POST WEIGHTS, SALINE GIVEN AND WHAT THE MACHINE INDICATED WAS REMOVED, THERE WAS FLUID WEIGHT LOSS VARIANCE OF APPROX 1.9KG. THE PT WAS DISCHARGED IN STABLE CONDITION.