MalfunctionFIL
FRESENIUS DIALYSIS DELIVERY SYSTEM
Received Aug 14, 2002 · Event occurred Jul 12, 2002
Report 2937457-2002-00038 · MDR key 412014
Device
Generic name
Hemodialysis Machine
Manufacturer
Fresenius Medical Care-north AmericaModel number
2008KCatalog number
NA
Lot number
NA
Product problems
- Insufficient Flow or Under Infusion
- Unknown (for use when the device problem is not known)
Patient
41 YR
- Nausea
- Vomiting
Narrative
Description of Event or Problem
A DIALYSIS FACILITY REPORTED THAT THE PATIENT C/O NAUSEA AND VOMITING DURING A HEMODIALYSIS TREATMENT AND RECEIVED A TOTAL OF 1,450 ML. OF SALINE. BASED ON THE REPORTED WEIGHTS, SALINE GIVEN AND WHAT THE MACHINE HAD INDICATED WAS REMOVED, THERE WAS A FLUID LOSS VARIANCE OF APPROXIMATELY 1.6 KG. THERE WAS NO MACHINE PROBLEM REPORTED. THE PATIENT WAS DISCHARGED IN STABLE CONDITION.