DeathFIL
2008K HEMODIALYSIS MACHINE
Received Sep 17, 2005 · Event occurred Sep 2, 2005
Report 636939 · MDR key 636939
Device
Generic name
Hemodialysis Machine
Manufacturer
Fresenius Medical Care;Model number
2008KCatalog number
UNK
Lot number
NA
Product problems
- Device Alarm System
- Material Separation
Patient
75 YR
- Death
- Blood Loss
Narrative
Description of Event or Problem
A PT UNDERGOING HEMODIALYSIS THERAPY EXPERIENCED SEPARATION OF THEIR VENOUS BLOOD LINE AND CENTRAL VENOUS CATHETER THAT WAS NOT DETECTED OR SIGNALED BY THE HEMODIALYSIS MACHINE MONITORING SYSTEM. A LARGE BLOOD LOSS RESULTED. THE PT EXPIRED SOON AFTER THE EVENT. FOUR (4) MINUTES PRIOR TO THE EVENT, THE VENOUS BLOOD LINE/CENTRAL VENOUS CATHETER CONNECTION HAD BEEN CHECKED AND FOUND TO BE SECURE AND WITH NO EVIDENCE OF LEAKAGE OR LOOSENING.