MalfunctionFIL
FRESENIUS DIALYSIS DELIVERY SYSTEM
Received Feb 12, 2002 · Event occurred Jan 14, 2002
Report 2937457-2002-00010 · MDR key 377066
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
- Cramp(s)
- Weight Changes
Narrative
Description of Event or Problem
FRESENIUS MEDICAL CARE CANADA RECEIVED A REPORT STATING THAT THERE WAS EXCESSIVE FLUID REMOVED DURING A HEMODIALYSIS TREATMENT. THE PT C/O SEVERE CRAMPS AFTER 3 HRS. BASED ON THE REPORTED WEIGHTS AND WHAT THE MACHINE HAD INDICATED WAS REMOVED, THERE WAS A WEIGHT LOSS VARIANCE OF APPROX 3.6 KG. THE PT HAD NORMAL BP AND WAS AMBULATORY POST TREATMENT.
Remedial action
- Notification
- Modification/Adjustment