DeathFIL
FRESENIUS DIALYSIS DELIVERY SYSTEM
Received May 11, 2005 · Event occurred Mar 31, 2005
Report 2937457-2005-00006 · MDR key 602557
Device
Generic name
Hemodialysis Machine
Manufacturer
Fresenius Medical Care-north AmericaModel number
2008KCatalog number
NA
Lot number
NA
Product problems
- Disconnection
- Unknown (for use when the device problem is not known)
Patient
79 YR
- Death
- Blood Loss
Narrative
Description of Event or Problem
FACILITY REPORTED THAT APPROXIMATELY 1-1.5 HRS INTO A HEMODIALYSIS TREATMENT, THERE WAS A DISCONNECTION BETWEEN THE BLOODLINE AND CENTRAL VENOUS CATHETER. APPROXIMATELY 600 CC OF BLOOD WAS LOST. A CODE WAS CALLED BUT THE PATIENT EXPIRED. THE HOSPITAL INDICATED THAT THE PATIENT HAD A HISTORY OF CONFUSION AND AGITATION AND MAY HAVE PULLED AT THE CONNECTION. IT COULD NOT BE DETERMINED IF THE MACHINE ALARMED.