DeathFIL
FRESENIUS DUALYSIS DELIVERY SYSTEM
Received Mar 22, 2002
Report 2937457-2002-00020 · MDR key 383986
Device
Generic name
Hemodialysis Machine
Manufacturer
Fresenius Medical Care-north AmericaModel number
2008KCatalog number
NA
Lot number
NA
Product problems
- Device Alarm System
- Source, detachment from
Patient
UNKNOWN
- Cardiopulmonary Arrest
- Death
- Blood Loss
Narrative
Description of Event or Problem
A DIALYSIS FACILITY REQUESTED TO HAVE A MACHINE EVALUATED AFTER AN ADVERSE EVENT. IT WAS REPORTED THAT THE VENOUS NEEDLE WAS PULLED OUT FROM THE PT'S ACCESS DURING A HEMODIALYSIS TREATMENT. THERE WAS REPORTEDLY NO MACHINE ALARM. ESTIMATED BLOOD LOSS WAS TWO LITERS. PT CODED AND EXPIRED. VENOUS WIDTH SELECTED WAS 200. NO OTHER INFO IS AVAILABLE.