MalfunctionFIL
FRESENIUS DIALYSIS DELIVERY SYSTEM
Received Jan 9, 2003 · Event occurred Dec 11, 2002
Report 2937457-2003-00002 · MDR key 437483
Device
Generic name
Hemodialysis Machine
Manufacturer
Fresenius Medical Care-north AmericaModel number
2008KCatalog number
NA
Lot number
NA
Product problems
- Leak/Splash
- Other (for use when an appropriate device code cannot be identified)
- Cut In Material
Patient
52 YR
- Therapy/non-surgical treatment, aborted/stopped
- Blood Loss
Narrative
Description of Event or Problem
BLOOD WAS NOTED TO BE DRIPPING FROM THE BLOOD PUMP HOUSING ON THE FRONT OF THE MACHINE AND ONTO THE FLOOR DURING A HEMODIALYSIS TREATMENT. TREATMENT WAS TERMINATED WITHOUT RETURNING THE PATIENT'S BLOOD IN THE EXTRACORPOREAL CIRCUIT. ESTIMATED TOTAL BLOOD LOSS WAS 300-350 CC. THERE WAS NO PATIENT COMPLICATION OR MEDICAL INTERVENTION. A CUT WAS NOTED ON THE BLOOD PUMP SEGMENT OF THE ARTERIAL BLOODLINE.