MalfunctionFIL
FRESENIUS DIALYSIS DELIVERY SYSTEM
Received Sep 26, 2001 · Event occurred Aug 28, 2001
Report 2937457-2001-00020 · MDR key 353904
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
48 YR
- Low Blood Pressure/ Hypotension
- Therapy/non-surgical treatment, additional
- Weight Changes
Narrative
Description of Event or Problem
A DIALYSIS FACILITY REPORTED THAT THERE WAS EXCESSIVE FLUID REMOVAL FROM A PT DURING A HEMODIALYSIS TREATMENT. THE PT BECAME HYPOTENSIVE ONE HOUR AND 15MINS INTO THE TREATMENT AND WAS GIVEN ONE LITER OF SALINE. PT WAS WEIGHED AFTER RECEIVING SALINE AND THEIR WEIGHT INDICATED THAT PT HAD LOST 4.7KG. THE MACHINE INDICATED THAT 2, 195ML HAD BEEN REMOVED. THE PT WAS DISCHARGED IN STABLE CONDITION AFTER RECEIVING ADDITIONAL SALINE. THERE WAS NO SERIOUS INJURY OR ILLNESS.