FRESENIUS DIALYSIS DELIVERY SYSTEM
Received Nov 1, 2004 · Event occurred Sep 28, 2004
Report 2937457-2004-00020 · MDR key 553440
Device
Generic name
Hemodialysis Machine
Manufacturer
Fresenius Medical Care-north AmericaModel number
2008KCatalog number
NA
Lot number
NA
Product problems
- Dislodged
Patient
83 YR
- Death
- Resuscitation
- Loss of consciousness
- Blood Loss
Narrative
Description of Event or Problem
A DIALYSIS FACILITY REPORTED THAT A PT'S VENOUS NEEDLE WAS DISLODGED DURING A HEMODIALYSIS TREATMENT AND RESULTED IN BLOOD LOSS OF APPROXIMATELY 1,500 CC. THERE WAS INITIALLY AN ARTERIAL PRESSURE ALARM. THE NURSE CHECKED THE ACCESS AND FOUND NO PROBLEM. SHE REDUCED THE BLOOD FLOW RATE AND RESET THE MACHINE. ABOUT 15 MINUTES LATER, THE PT WAS FOUND UNRESPONSIVE WITH THE VENOUS NEEDLE DISLODGED. CPR WAS INITIATED. THEY WERE UNABLE TO REINFUSE THE EXTRACORPOREAL BLOOD DUE TO AN ALARM THAT COULD NOT BE CLEARED. THE VENOUS PRESSURE READING AND THE ALARM WIDTH SELECTED ARE UNK.