MalfunctionFIL
FRESENIUS DIALYSIS DELIVERY SYSTEM
Received Apr 10, 2002 · Event occurred Mar 21, 2002
Report 2937457-2002-00025 · MDR key 389742
Device
Generic name
Hemodialysis Machine
Manufacturer
Fresenius Medical Care-north AmericaModel number
2008KCatalog number
NA
Lot number
NA
Product problems
- Underdelivery
Patient
UNKNOWN
- Cramp(s)
- Other (for use when an appropriate patient code cannot be identified)
- Therapy/non-surgical treatment, aborted/stopped
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
A DIALYSIS FACILITY REPORTED THAT A PT C/O CRAMPS DURING A HEMODIALYIS TREATMENT. THE PT WAS GIVEN A TOTAL OF 800 CC. OF SALINE AND TREATMENT WAS DISCONTINUED 20 MINUTES EARLY. BASED ON THE REPORTED PRE AND POST WEIGHTS, SALINE GIVEN AND WHAT THE MACHINE INDICATED WAS REMOVED, THERE WAS A WEIGHT LOSS VARIANCE OF 1.2 KG. THERE WAS NO SERIOUS INJURY OR ILLNESS.