MalfunctionFIL
FRESENIUS DIALYSIS DELIVERY SYSTEM
Received Oct 11, 2001 · Event occurred Sep 3, 2001
Report 2937457-2001-00023 · MDR key 356096
Device
Generic name
Hemodialysis Machine
Manufacturer
Fresenius Medical Care-north AmericaModel number
2008KCatalog number
NA
Lot number
NA
Product problems
- Insufficient Flow or Under Infusion
Patient
39 YR
- Low Blood Pressure/ Hypotension
- Nausea
- Dizziness
- Therapy/non-surgical treatment, additional
- Treatment with medication(s)
- 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 PATIENT BECAME HYPOTENSIVE AND C/O NAUSEA AND DIZZINESS ONE AND A HALF HOUR INTO THE TREATMENT. PATIENT WAS GIVEN A LITER OF SALINE AND WEIGHED. PATIENT'S WEIGHT INDICATED A WEIGHT LOSS OF 4.2 KG. THE MACHINE SHOWED THAT 2,710 ML WAS REMOVED. ADDITIONAL SALINE WAS GIVEN AND TREATMENT WAS COMPLETED WITH THE "UF" OFF. THERE WAS NO SERIOUS INJURY OR ILLNESS.