MalfunctionFIL
FRESENIUS DIALYSIS DELIVERY SYSTEM
Received Feb 15, 2002 · Event occurred Dec 22, 2001
Report 2937457-2002-00011 · MDR key 378036
Device
Generic name
Hemodialysis Machine
Manufacturer
Fresenius Medical Care-north AmericaModel number
2008KCatalog number
NA
Lot number
NA
Product problems
- Output, high
Patient
UNKNOWN
- Low Blood Pressure/ Hypotension
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
FRESENIUS MEDICAL CARE CANADA, INC. REPORTED THAT THERE WAS EXCESSIVE FLUID REMOVED DURING A HEMODIALYSIS TREATMENT. THE PATIENT BECAME HYPOTENSIVE 35 MINUTES INTO THE TREATMENT AND WAS GIVEN 500 ML. OF SALINE. BASED ON THE PRE AND POST WEIGHTS REPORTED, SALINE GIVEN AND WHAT THE MACHINE INDICATED WAS REMOVED, THERE WAS A WEIGHT LOSS VARIANCE OF APPROXIMATELY 2.8 KG. THERE WAS NO SERIOUS INJURY OR ILLNESS.