MalfunctionFIL
FRESENIUS DIALYSIS DELIVERY SYSTEM
Received Feb 1, 2007 · Event occurred Jan 2, 2007
Report 2937457-2007-00002 · MDR key 817697
Device
Generic name
Hemodialysis Machine
Manufacturer
Fresenius Medical Care North AmericaModel number
2008KCatalog number
NA
Lot number
NA
Product problems
- Output above Specifications
- Unknown (for use when the device problem is not known)
Patient
65 YR
- Low Blood Pressure/ Hypotension
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
A DIALYSIS FACILITY REPORTED THAT A MACHINE REMOVED TOO MUCH FLUID FROM A PT DURING A HEMODIALYSIS TREATMENT. THE PT BECAME HYPOTENSIVE AND WAS GIVEN A TOTAL OF 700 ML OF SALINE. BASED ON THE REPORTED PRE AND POST WEIGHTS, SALINE GIVEN AND WHAT THE MACHINE HAD INDICATED WAS REMOVED, THERE WAS A FLUID WEIGHT LOSS VARIANCE OF 1.9 KG. THERE WAS NO SERIOUS INJURY.