MalfunctionFIL
FRESENIUS DIALYSIS DELIVERY SYSTEM
Received Feb 15, 2002 · Event occurred Dec 22, 2001
Report 2937457-2002-00012 · MDR key 378038
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
- Abdominal Cramps
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 AND C/O CRAMPS 13 MINUTES BEFORE THE END OF TREATMENT AND RECEIVED A LITER 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 2.5 KG. THERE WAS NO SERIOUS INJURY OR ILLNESS.