MalfunctionFII
*
Received Dec 5, 2009 · Event occurred Nov 25, 2009
Report 1562362 · MDR key 1562362
Device
Generic name
Hemodialysis Machine
Manufacturer
Fresenius Medical Care North AmericaModel number
*Catalog number
*
Lot number
*
Product problems
- Device Inoperable
Patient
52 YR
- Blood Loss
Narrative
Description of Event or Problem
BLOOD PUMP MALFUNCTIONED ON HEMODIALYSIS MACHINE. AN ATTEMPT WAS MADE TO MANUALLY RETURN PATIENT'S BLOOD WITHOUT SUCCESS. NO TRUE INJURY. HOWEVER, PATIENT DID LOSE APPROXIMATELY 250 CC OF BLOOD.