MalfunctionFIL
FRESENIUS DIALYSIS DELIVERY SYSTEM
Received Jun 25, 2003 · Event occurred May 27, 2003
Report 2937457-2003-00019 · MDR key 469190
Device
Generic name
Hemodialysis Machine
Manufacturer
Fresenius Medical Care-north AmericaModel number
2008KCatalog number
NA
Lot number
NA
Product problems
- Device Alarm System
- Leak/Splash
- Replace
Patient
UNKNOWN
- Therapy/non-surgical treatment, aborted/stopped
- Blood Loss
Narrative
Description of Event or Problem
THERE WAS AN EXTERNAL AND INTERNAL DIALYZER BLOOD LEAK A FEW MINUTES AFTER HEMODIALYSIS TREATMENT WAS STARTED. BLOOD ON THE FLOOR AND WAS ESTIMATED TO BE AROUND 300 CC. BLOOD WAS ALSO VISIBLE IN THE DIALYSATE LINES AND THERE WAS NO MACHINE ALARM. THE EXTRACORPOREAL CIRCUIT WAS DISCARDED AND TREATMENT WAS RESUMED ON ANOTHER MACHINE. THERE WAS NO PT COMPLICATION AND NO BLOOD TRANSFUSION WAS NECESSARY.