InjuryFIL
FRESENIUS DIALYSIS DELIVERY SYSTEM
Received Apr 18, 2002 · Event occurred Jan 9, 2002
Report 2937457-2002-00026 · MDR key 389467
Device
Generic name
Hemodialysis Machine
Manufacturer
Fresenius Medical Care-north AmericaModel number
2008KCatalog number
NA
Lot number
NA
Product problems
- Underdelivery
Patient
34 YR
- Dehydration
- Weakness
- Hospitalization required
Narrative
Description of Event or Problem
THIS IS ONE OF THE FOUR EVENTS REPORTED IN A PREVIOUSLY SUBMITTED MEDWATCH REPORT (00023). ADDITIONAL INFORMATION WAS RECEIVED ON 4/2002. THIS PATIENT RECEIVED A TOTAL OF 800 CC. DURING A HEMODIALYSIS TREATMENT AND COMPLAINED OF GENERALIZED WEAKNESS POST TREATMENT. THE PT'S PRE AND POST WEIGHTS INDICATED A WEIGHT LOSS OF 3.9 KG. (AFTER RECEIVING SALINE). THE MACHINE SHOWED THAT 2,906 ML WAS REMOVED. THE PT WAS DISCHARGED HOME AND WAS LATER TAKEN TO THE HOSPITAL. THE PT WAS BELIEVED TO BE DEHYDRATED.