MalfunctionFIL
FRESENIUS DIALYSIS DELIVERY SYSTEM
Received Dec 19, 2001 · Event occurred Nov 17, 2001
Report 2937457-2001-00032 · MDR key 368333
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
Patient
69 YR
- Low Blood Pressure/ Hypotension
- Weight Changes
Narrative
Description of Event or Problem
A DIALYSIS FACILITY REPORTED THAT THERE WAS EXCESSIVE FLUID REMOVED FROM A PATIENT DURING A HEMODIALYSIS TREATMENT. THE PT BECAME HYPOTENSIVE AND RECEIVED A TOTAL OF 2 LITERS OF SALINE THROUGHOUT THE TREATMENT. BASED ON THE PRE AND POST WEIGHTS, THE PATIENT LOST 1.4 KG. WHEN PT WAS EXPECTED TO GAIN 1.6 KG. FROM THE AMOUNT OF SALINE GIVEN THE MACHINE SHOWED THAT 405 ML. WAS REMOVED. THERE WAS NO SERIOUS INJURY/ILLNESS.