OtherFKP
FRESENIUS HEMODIALYZER
Received Mar 15, 2004 · Event occurred Dec 3, 2003
Report 518739 · MDR key 518739
Device
Generic name
Hemodialyzer
Manufacturer
Fresenius Medical CareModel number
F8Catalog number
NA
Lot number
UNK
Product problems
- Unknown (for use when the device problem is not known)
Patient
78 YR
- Low Blood Pressure/ Hypotension
- Unspecified Infection
- Vomiting
- Chills
Narrative
Description of Event or Problem
PT EXPERIENCED CHILLS, VOMITING AND HYPOTENSION DURING HEMODIALYSIS THERAPY. THERAPY WAS PROVIDED WITH AN 11TH-USE HEMODIALYZER.